spacer
The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Searching News Database:  Priority Review 

 HSMN NewsFeed - 28 Jan 2026
REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs
Regenerative Medicine FDA
 HSMN NewsFeed - 19 Jan 2026
FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to iRegene's NouvNeu001, Making It the World's First iPSC Therapy with Both FTD and RMAT Recognitions
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 15 Oct 2025
CAPS Medical's PlasmaSure(TM) Receives FDA Breakthrough Device Designation
Devices Oncology FDA
 HSMN NewsFeed - 11 Aug 2025
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 8 Jul 2025
Soligenix Corporate Update Letter - Key Highlights and Upcoming Milestones
Biopharmaceuticals Oncology
 HSMN NewsFeed - 5 Mar 2025
Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio
Biopharmaceuticals Oncology Mergers & Acquisitions
 HSMN NewsFeed - 10 Feb 2025
Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 27 Nov 2024
PTC Therapeutics Enters into Agreement to Sell Priority Review Voucher for $150 Million
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Sep 2024
FDA Grants Fast Track Designation to PTC518 Huntington's Disease Program
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 20 Aug 2024
RYBREVANT(R) (amivantamab-vmjw) Plus LAZCLUZE(TM) (lazertinib) Approved in the U.S. as a First-line Chemotherapy-free Treatment for Patients with EGFR-mutated Advanced Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Jul 2024
Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Jul 2024
Latigo Biotherapeutics Appoints Nima Farzan as Chief Executive Officer, Positioning Company for Rapid Growth
Biopharmaceuticals Personnel
 HSMN NewsFeed - 24 Jun 2024
Harmony Biosciences Receives U.S. Food And Drug Administration Approval For Wakix(R) (Pitolisant) In Pediatric Patients With Narcolepsy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 12 Jun 2024
REGENXBIO Announces Leadership Transition
Biopharmaceuticals Personnel
 HSMN NewsFeed - 8 Apr 2024
Mitsubishi Tanabe Pharma America Receives U.S. Food and Drug Administration Orphan Drug Exclusivity for RADICAVA ORS(R) (edaravone)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 20 Feb 2024
Avidity Biosciences Receives FDA Rare Pediatric Disease Designation for AOC 1044 for Treatment of Duchenne Muscular Dystrophy in People with Mutations Amenable to Exon 44 Skipping
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Dec 2023
CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Aug 2023
FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 May 2023
Soligenix Announces Positive Clinical Results from Compatibility Study of HyBryte(TM) in the Treatment of Cutaneous T-Cell Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 14 Apr 2023
Soligenix Provides Regulatory Update on HyBryte(TM)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Feb 2023
FDA approves once-weekly efanesoctocog alfa, a new class of high-sustained factor VIII therapy for haemophilia A: Swedish Orphan Biovitrum AB
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Feb 2023
Soligenix Receives Refusal to File Letter from U.S. FDA for HyBryte(TM) New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Jan 2023
Cadrenal Therapeutics (Nasdaq: CVKD) Granted FDA Fast Track Designation for Tecarfarin for Prevention of Systemic Thromboembolism of Cardiac Origin in Patients with End-Stage Renal Disease and Atrial Fibrillation
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Dec 2022
Harm Reduction Therapeutics' New Drug Application for RiVive(TM) Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 21 Oct 2022
Regeneron Receives Six Months of U.S. Pediatric Exclusivity for EYLEA(R) (aflibercept) Injection
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 18 Aug 2022
U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Jul 2022
Daewoong Pharmaceutical Gets First Korean US FDA Fast-Track for New Idiopathic Pulmonary Fibrosis Drug
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Jul 2022
Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Jan 2022
Amber Implants Closes US$10 M Series A Financing
Devices Orthopaedic Neurosurgery Venture Capital
 HSMN NewsFeed - 15 Dec 2021
FDA Approves First Drug to Prevent Graft Versus Host Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Nov 2021
BioMarin Receives FDA Approval for VOXZOGO(TM) (vosoritide) for Injection, Indicated to Increase Linear Growth in Children with Achondroplasia Aged 5 and Up with Open Growth Plates
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Oct 2021
Amber Implants VCFix(R) spinal system receives US FDA Breakthrough designation
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 27 Sep 2021
Japan's MHLW Approves PADCEV(R) (enfortumab vedotin) for Advanced Urothelial Cancer
Biopharmaceuticals Urology Oncology Regulatory
 HSMN NewsFeed - 27 Aug 2021
European Commission Approves BioMarin's VOXZOGO(R) (vosoritide) for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 6 Aug 2021
FDA Approves New Treatment for Pompe Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Aug 2021
Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 19 Jul 2021
BlueRock Therapeutics Receives FDA Fast Track Designation for DA01 in the Treatment of Advanced Parkinson's Disease
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 25 Jun 2021
Jazz Pharmaceuticals Announces Orphan Drug Exclusivity for Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Jun 2021
BioMarin Receives Positive CHMP Opinion in Europe for Vosoritide for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 4 May 2021
Theseus Pharmaceuticals Appoints Tim Clackson, Ph.D., as Chief Executive Officer
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 28 Apr 2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Apr 2021
Medtronic Receives FDA Breakthrough Designation for the Emprint(TM) Ablation Catheter Kit
Devices FDA
 HSMN NewsFeed - 5 Apr 2021
IceCure Medical Granted FDA Breakthrough Device Designation for ProSense(R) Cryoablation System
Devices Oncology FDA
 HSMN NewsFeed - 31 Mar 2021
CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Mar 2021
MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 12 Feb 2021
Mallinckrodt Provides Regulatory Update on StrataGraft(R)
Devices Dermatology FDA
 HSMN NewsFeed - 12 Feb 2021
The Lancet Publishes Libtayo(R) (cemiplimab) Data Showing Extended Overall Survival in Patients with First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%
Biopharmaceuticals Oncology
 HSMN NewsFeed - 11 Feb 2021
BrainCool AB (publ) Receives FDA "Breakthrough Device" Designation for Cooral(R) System for Prevention of Oral Mucositis
Devices FDA
 HSMN NewsFeed - 30 Dec 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease
Biopharmaceuticals
 HSMN NewsFeed - 22 Dec 2020
Soligenix Announces Topline Results from its Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients
Biopharmaceuticals Oncology
 HSMN NewsFeed - 18 Dec 2020
Polaryx Therapeutics Receives Both Rare Pediatric Disease and Orphan Drug Designations for the Treatment of Niemann Pick Disease Types A and B With PLX-300
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 17 Dec 2020
FDA Approves GSK's BENLYSTA as the First Medicine for Adult Patients with Active Lupus Nephritis in the US
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Dec 2020
ReCor Medical Announces Positive Results in RADIANCE-HTN TRIO Study and Breakthrough Device Designation for Paradise(TM) Ultrasound Renal Denervation System
Devices Cardiology FDA
 HSMN NewsFeed - 27 Nov 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Nov 2020
Eiger BioPharmaceuticals Announces FDA Approval of Zokinvy(TM) (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Oct 2020
BioMarin, Pioneer in Phenylketonuria (PKU) and Gene Therapy, Receives FDA Fast Track Designation for PKU Investigational Gene Therapy, BMN 307
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Sep 2020
Innovent Announces NMPA Granted Marketing Approval for SULINNO(R) (Adalimumab Injection) in China
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 25 Aug 2020
FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Aug 2020
Innovent and Lilly Announce Expansion of TYVYT(R) (Sintilimab Injection) Licensing Agreement
Biopharmaceuticals Oncology Licensing
 HSMN NewsFeed - 12 Aug 2020
FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 12 Aug 2020
Innovent and Eli Lilly Announce Acceptance of a Supplemental New Drug Application of TYVYT(R) (Sintilimab Injection) in Combination with Gemcitabine and Platinum as First-Line Therapy in Squamous Non-Small Cell Lung Cancer in China
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 10 Aug 2020
Mallinckrodt Announces U.S. FDA Filing Acceptance of Biologics License Application for StrataGraft(R) Regenerative Skin Tissue for Treatment of Adults with Deep Partial-thickness Thermal Burns
Biopharmaceuticals Regenerative Medicine FDA
 HSMN NewsFeed - 3 Aug 2020
FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ(R) (tasimelteon) in the Treatment of Smith-Magenis Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Jul 2020
HemoShear Therapeutics Receives FDA Fast Track and Rare Pediatric Disease Designations for HST5040 to Treat Methylmalonic Acidemia and Propionic Acidemia
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Jun 2020
Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Jun 2020
F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever) and FDA QIDP Designation for Multiple Fungal Infections
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Jun 2020
Insmed Receives FDA Breakthrough Therapy Designation for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFBE)
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 May 2020
Cardiff Oncology Announces Fast Track Designation Granted by the FDA to Onvansertib for Second-Line Treatment of KRAS-Mutated Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 May 2020
Soligenix Announces Recent Accomplishments And First Quarter 2020 Financial Results
Biopharmaceuticals
 HSMN NewsFeed - 5 May 2020
Akebia Therapeutics Announces Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis
Biopharmaceuticals
 HSMN NewsFeed - 30 Apr 2020
Soligenix Announces Positive Phase 3 FLASH Study Demonstrates Increased Efficacy with Continued Treatment in Patients with Cutaneous T-Cell Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 16 Apr 2020
Provention Bio Initiates Rolling Submission of Biologic License Application for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Apr 2020
Blueprint Medicines Announces the Achievement of Key Portfolio Milestones
Biopharmaceuticals Oncology
 HSMN NewsFeed - 18 Mar 2020
Biohaven's Verdiperstat Receives Fast Track Designation For The Treatment Of Multiple System Atrophy
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Mar 2020
Agenus Receives Fast Track Designation for Balstilimab & Zalifrelimab in Advanced Cervical Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 3 Mar 2020
FDA Grants Rare Pediatric Disease Designation to Stealth BioTherapeutics for Elamipretide for the Treatment of Barth Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Feb 2020
PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Feb 2020
Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Jan 2020
Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Jan 2020
Aruvant Receives FDA Rare Pediatric Disease Designation for ARU-1801 for the Treatment of Sickle Cell Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Dec 2019
Results of Fully-human BCMA CAR-T for the Treatment of Relapsed/Refractory Multiple Myeloma Co-developed by Innovent and IASO BIO Presented at the 2019 ASH Annual Meeting
Biopharmaceuticals Oncology
 HSMN NewsFeed - 6 Dec 2019
3DBio Therapeutics Receives FDA Rare Pediatric Disease Designation for AuriNovo(TM) for Ear Reconstruction in Microtia Patients
Devices Regenerative Medicine FDA
 HSMN NewsFeed - 4 Dec 2019
Vicarious Surgical Announces Breakthrough Designation by the FDA, Appoints Scott Huennekens to Board of Directors
Devices Surgery FDA Personnel
 HSMN NewsFeed - 11 Nov 2019
Allergan Receives FDA Qualified Infectious Disease Product (QIDP) Designation And Fast Track Designation For ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Sep 2019
Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Jun 2019
FDA Approves BOTOX(R) (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Jun 2019
FDA Grants Fast Track Designation for Torque's First Deep-Primed T Cell Cancer Immunotherapy Program, TRQ-1501
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Jun 2019
Sobi Acquires Emapalumab and Related Assets
Biopharmaceuticals Acquisitions
 HSMN NewsFeed - 2 May 2019
Concept Medical Inc. Granted 'Breakthrough Device Designation' From FDA for Its MagicTouch Sirolimus Coated Balloon
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 29 Apr 2019
U.S. FDA Accepts New Drug Application and Grants Priority Review for Darolutamide
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Apr 2019
Aprea Therapeutics Receives FDA Fast Track Designation and Orphan Drug Designation for APR-246 for the Treatment of Myelodysplastic Syndromes (MDS)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Apr 2019
Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Mar 2019
Enzyvant's Investigational Farber Disease Enzyme Replacement Therapy, RVT-801, Receives FDA Fast Track and Rare Pediatric Disease Designations
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Mar 2019
FDA Accepts Supplemental Biologics License Applications (sBLAs) for BOTOX(R) (onabotulinumtoxinA) for Pediatric Patients with Upper and Lower Limb Spasticity
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Feb 2019
FDA Approves Taiho Oncology's LONSURF(R) (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 19 Feb 2019
AbbVie Announces New Drug Application Accepted for Priority Review by U.S. FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Feb 2019
FDA Grants Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Cryptococcosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Jan 2019
European Commission Approves BLINCYTO(R) (blinatumomab) In Patients With Philadelphia Chromosome Negative Minimal Residual Disease-Positive B-cell Precursor Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 31 Dec 2018
FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management
Biopharmaceuticals Surgery FDA
 HSMN NewsFeed - 5 Dec 2018
Olympus Spiration(R) Valve System Is FDA Approved for the Endobronchial Treatment of Emphysema
Devices FDA
 HSMN NewsFeed - 20 Nov 2018
FDA Approves Gamifant(R) (emapalumab), the First and Only Treatment for Primary Haemophagocytic Lymphohistiocytosis (HLH)
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Oct 2018
Eiger BioPharmaceuticals Receives FDA Rare Pediatric Disease (RPD) Designation for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies and Plans NDA Filing in 2019
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Oct 2018
AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA(R) (ibrutinib) in Combination with Obinutuzumab (GAZYVA(R)) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 Oct 2018
Soligenix Announces Positive Recommendation by Independent Data Monitoring Committee on its Phase 3 Clinical Trial of SGX301 for the Treatment of Cutaneous T-cell Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 1 Oct 2018
FDA Approves KYPROLIS(R) (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone (Kd70) For Patients With Relapsed Or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 Sep 2018
CASI Pharmaceuticals Announces $48.5 Million Private Placement
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 4 Sep 2018
Genoptix Launches FDA-Authorized BCR-ABL MRDx(R) TFR Monitoring Test for Patients with Chronic Myeloid Leukemia on Tasigna(R) (nilotinib)
Diagnostics Oncology Product Launch
 HSMN NewsFeed - 3 Sep 2018
Cablivi(TM) (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura (aTTP)
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 29 Aug 2018
European Commission Approves BLINCYTO(R) (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 27 Aug 2018
AbbVie Announces IMBRUVICA(R) (ibrutinib) Plus Rituximab Approval by U.S. FDA as First Chemotherapy-Free Combination Treatment in Adults with Waldenström's Macroglobulinemia, a Rare Type of Blood Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Jul 2018
AbbVie Receives U.S. FDA Approval of ORILISSA(TM) (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
Biopharmaceuticals FDA Product Launch
 HSMN NewsFeed - 26 Jun 2018
Salix And US WorldMeds Enter Into Exclusive Co-Promotion Agreement For Opioid Withdrawal Treatment LUCEMYRA(TM) (lofexidine)
Biopharmaceuticals Distribution
 HSMN NewsFeed - 25 Jun 2018
IMBRUVICA(R) (ibrutinib) Supplemental New Drug Application Accepted for Review by U.S. FDA with Potential to Broaden Treatment Use as a Combination Treatment Option with Rituximab in Waldenström's Macroglobulinemia (WM), A Rare Form of Blood Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Jun 2018
Partner Therapeutics (PTx) Announces US FDA Approval of Leukine(R) (sargramostim) for the Treatment of Acute Radiation Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 May 2018
Curis Announces FDA Fast Track Designation for Fimepinostat Development in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 May 2018
FDA expedites review of Novartis drug Promacta(R) for first-line severe aplastic anemia (SAA)
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 May 2018
U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 May 2018
Immunicom's Immunotherapy Product Receives U.S. FDA Breakthrough Device Designation for the Treatment of Cancer
Devices Oncology FDA
 HSMN NewsFeed - 1 May 2018
SCYNEXIS's Oral SCY-078 Receives FDA QIDP and Fast Track Designations for the Treatment of VVC and Prevention of Recurrent VVC
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Apr 2018
FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 25 Apr 2018
FDA Grants Fast Track Designation for OrphoMed's ORP-101 for Treatment of IBS-D
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 4 Apr 2018
Proteostasis Therapeutics Receives FDA Fast Track Designation for Triple Combination Program in Patients with Cystic Fibrosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Mar 2018
Amgen Receives Positive CHMP Opinion Recognizing That Repatha(R) (evolocumab) Prevents Heart Attacks And Strokes
Biopharmaceuticals Cardiology Regulatory
 HSMN NewsFeed - 19 Mar 2018
Amplyx Pharmaceuticals Receives Fourth "Qualified Infectious Disease Product" (QIDP) Designation from the FDA for APX001
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Mar 2018
U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 13 Feb 2018
Mallinckrodt Completes Acquisition Of Sucampo Pharmaceuticals, Inc.
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 8 Feb 2018
SIGA Technologies Announces FDA Accepts NDA and Grants Priority Review for Oral TPOXX to Treat Smallpox
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Feb 2018
Appointment of Jonathan E. Gold as Interim Chief Financial Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 2 Feb 2018
FDA Approves AVYCAZ(R) (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Feb 2018
Partner Therapeutics (PTx) Acquires Leukine(R) from Sanofi
Biopharmaceuticals Oncology Acquisitions
 HSMN NewsFeed - 17 Jan 2018
Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Dec 2017
Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for AZEDRA(R) (iobenguane I 131) in Pheochromocytoma and Paraganglioma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 Dec 2017
GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex(R) (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 26 Dec 2017
Mallinckrodt To Acquire Sucampo Pharmaceuticals For Approximately $1.2 Billion
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 22 Dec 2017
Novartis' combination therapy Tafinlar(R) + Mekinist(R) granted FDA Priority Review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Dec 2017
FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Dec 2017
DARZALEX(R) (daratumumab) Combination Regimen Significantly Improved Outcomes for Newly Diagnosed Multiple Myeloma Patients who are Transplant Ineligible
Biopharmaceuticals Oncology
 HSMN NewsFeed - 27 Nov 2017
Stealth BioTherapeutics Granted Fast Track Designation for the Treatment of Barth Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2017
U.S. FDA Approves Kaléo's AUVI-Q(R) (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children
Biopharmaceuticals Devices Drug Delivery FDA
 HSMN NewsFeed - 16 Nov 2017
FDA Approves New Treatment to Prevent Bleeding in Certain Patients with Hemophilia A
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Nov 2017
FDA Announces Comprehensive Regenerative Medicine Policy Framework
Regenerative Medicine FDA
 HSMN NewsFeed - 15 Nov 2017
Noden Pharma Announces FDA Approval of Tekturna(R) (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 30 Oct 2017
FDA Approves New 10 mg Dosing for XARELTO(R) (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE)
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Oct 2017
AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Oct 2017
FDA Grants Priority Review for Potential New Indication for Lilly's Verzenio(TM) (abemaciclib) as Initial Treatment of Advanced Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Sep 2017
Regeneron and Sanofi Announce Cemiplimab (REGN2810) Has Received FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous Cell Carcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 31 Aug 2017
U.S. FDA Approves Chemo Group's Benznidazole to Treat Children with Chagas Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Jul 2017
FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For Repatha(R) (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 27 Jul 2017
U.S. FDA Grants Priority Review for an Epinephrine Auto-Injector in Development by Kaléo Specifically for Infants and Small Children
Biopharmaceuticals Devices Drug Delivery FDA
 HSMN NewsFeed - 27 Jul 2017
Eiger Announces FDA Fast Track Designation Granted for Pegylated Interferon Lambda in Hepatitis Delta Virus Infection
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Jul 2017
Capricor Receives Rare Pediatric Disease Designation from FDA for CAP-1002 for Patients with Duchenne Muscular Dystrophy
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Jul 2017
U.S. FDA Designates Mallinckrodt's StrataGraft(R) as Regenerative Medicine Advanced Therapy
Regenerative Medicine FDA
 HSMN NewsFeed - 10 Jul 2017
FDA Grants Priority Review for Lilly's Abemaciclib for the Treatment of Advanced Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 May 2017
Ultragenyx Announces Recombinant Human Beta-Glucuronidase Biologics License Application and Marketing Authorization Application Filed and Accepted for Review; FDA Grants Priority Review Status
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 May 2017
Rhythm Receives Expanded FDA Breakthrough Therapy Designation for Setmelanotide for Rare Genetic Disorders of Obesity
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Apr 2017
Novartis Receives FDA Approval for Rydapt(R) in Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) and Three Types of Systemic Mastocytosis (SM)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Apr 2017
Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR(12) Rates in Challenging to Treat Genotype 3 Chronic Hepatitis C
Biopharmaceuticals
 HSMN NewsFeed - 18 Apr 2017
Novartis CAR-T cell therapy CTL019 receives FDA Breakthrough Therapy designation for treatment of adult patients with r/r DLBCL
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 Mar 2017
Sanofi and Regeneron Announce FDA Approval of Dupixent(R) (dupilumab), the First Targeted Biologic Therapy for Adults with Moderate-to-Severe Atopic Dermatitis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 24 Mar 2017
FDA Grants Approval for BAVENCIO(R) (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology FDA Product Launch
 HSMN NewsFeed - 21 Mar 2017
Pain Therapeutics Announces Positive Regulatory Guidance for REMOXY(TM) ER
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 16 Mar 2017
Biostage Promotes Saverio La Francesca, M.D. to President
Devices Regenerative Medicine Personnel
 HSMN NewsFeed - 2 Mar 2017
BLINCYTO(R) (blinatumomab) Significantly Improved Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia Compared To Chemotherapy
Biopharmaceuticals Oncology
 HSMN NewsFeed - 16 Feb 2017
FDA Expands Approval of SPIRIVA(R) RESPIMAT(R) (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Feb 2017
FDA Approves EMFLAZA(TM) (deflazacort) Tablets and Oral Suspension for the Treatment of Duchenne Muscular Dystrophy in Patients 5 Years and Older
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Jan 2017
FDA Grants Priority Review for Genentech’s Actemra(R) (Tocilizumab) Supplemental Biologics License Application for Giant Cell Arteritis, a Form of Vasculitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Jan 2017
ViraCyte Granted U.S. FDA Fast Track Designation for Viralym-C
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Jan 2017
Ascletis Raises US$100 Million in Series B Financing
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 26 Dec 2016
SPINRAZA(TM) (nusinersen) Approved in U.S. to Treat Broad Range of Patients with Spinal Muscular Atrophy
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Dec 2016
Positive Phase III Results of Genentech’s Investigational Medicine OCREVUS(TM) (Ocrelizumab) Published in New England Journal of Medicine
Biopharmaceuticals Neurology
 HSMN NewsFeed - 19 Dec 2016
Tonix Pharmaceuticals’ PTSD Phase 3-Ready Drug Candidate, TNX-102 SL, Granted Breakthrough Therapy Designation by the FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Dec 2016
Regeneron and Sanofi Announce Marketing Authorization Application for Dupixent(R) (dupilumab) Accepted for Review by the EMA
Biopharmaceuticals Dermatology Regulatory
 HSMN NewsFeed - 7 Dec 2016
Neovacs obtains FDA “Fast Track” designation for IFNα Kinoid in Lupus (SLE)
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Nov 2016
Neurocrine Announces FDA Advisory Committee Meeting to Review INGREZZA(TM) (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 28 Nov 2016
Conditional Approval from the European Commission to Treat Multiple Myeloma
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 17 Nov 2016
FDA Grants Fast Track Designation for Development of E2609, Eisai's BACE Inhibitor for Early Alzheimer's Disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 24 Oct 2016
aTyr Pharma Receives FDA Fast Track Designation for Resolaris(TM) to Treat Facioscapulohumeral Muscular Dystrophy (FSHD)
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Oct 2016
Neurocrine Announces INGREZZA(TM) (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by U.S. FDA
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 11 Oct 2016
FDA Grants Priority Review to Genentech’s Lucentis(R) (Ranibizumab Injection) Supplemental Biologics License Application for Myopic Choroidal Neovascularization
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 26 Sep 2016
Regeneron and Sanofi Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 22 Sep 2016
Sanaria(R) PfSPZ Vaccine Against Malaria Receives FDA Fast Track Designation
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Sep 2016
Advanced Accelerator Applications Announces Revised EMA Review Timeline for Lutathera(R)
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 16 Sep 2016
CHMP Recommends Approval of Lilly's Olaratumab, in Combination with Doxorubicin, for Advanced Soft Tissue Sarcoma
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 12 Sep 2016
Soligenix and SciClone Establish Regional Licensing Agreement for SGX942, a Novel Product Candidate for Oral Mucositis
Biopharmaceuticals Licensing
 HSMN NewsFeed - 7 Sep 2016
FDA Grants Special Designation to TAXIS Pharmaceuticals Experimental Antibiotic
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Aug 2016
Takeda Receives Marketing Authorization in Canada for NINLARO(TM) (ixazomib) in Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 28 Jul 2016
Caladrius Biosciences Receives FDA Fast Track Designation for CLBS03 to Treat Recent Onset Type 1 Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 6 Jul 2016
US FDA pathway opens to SCENESSE(R) following Fast Track designation for treatment of EPP
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Jun 2016
FDA Grants Priority Review for Genentech’s OCREVUS(TM) (ocrelizumab) Biologics License Application
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 17 May 2016
Catalyst Pharmaceuticals Announces Reduction in Workforce as Part of Operating Expense Management Plan
Biopharmaceuticals
 HSMN NewsFeed - 9 May 2016
Elite Pharmaceuticals to Present SequestOx(TM) Data at the American Pain Society 35th Annual Scientific Meeting
Biopharmaceuticals Drug Delivery
 HSMN NewsFeed - 11 Apr 2016
FDA Grants Priority Review for Genentech’s Cancer Immunotherapy Atezolizumab in Specific Type of Lung Cancer
Biopharmaceuticals Personalized Medicine Oncology FDA
 HSMN NewsFeed - 29 Mar 2016
Pain Therapeutics Resubmits REMOXY New Drug Application to the U.S. Food and Drug Administration
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 17 Mar 2016
Elite Announces U.S. FDA Priority Review Designation for SequestOx(TM) NDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Feb 2016
Catalyst Pharmaceuticals Appoints Brian Elsbernd as Senior Vice President of Legal and Compliance
Biopharmaceuticals Personnel
 HSMN NewsFeed - 24 Feb 2016
FDA Accepts and Grants Priority Review for AVYCAZ(R) (ceftazidime and avibactam) Supplemental New Drug Application (sNDA)
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Feb 2016
Catalyst Pharmaceuticals Receives "Refusal to File" Letter From the FDA on Its NDA for Firdapse
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Feb 2016
Amarantus Requests Rare Pediatric Disease Designation from US FDA for MANF in the Treatment of Retinitis Pigmentosa
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 4 Feb 2016
Phase 3 Study of BLINCYTO(R) (Blinatumomab) Met Primary Endpoint Of Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology
 HSMN NewsFeed - 1 Feb 2016
Proteostasis Therapeutics Receives FDA Fast Track Designation for PTI-428 in Patients With Cystic Fibrosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Jan 2016
FDA Approves Eisai's Halaven(R) (eribulin mesylate) Injection for the Treatment of Patients with Advanced Liposarcoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Jan 2016
Merck Receives FDA Approval of ZEPATIER(TM) (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review
Biopharmaceuticals FDA Product Launch
 HSMN NewsFeed - 28 Jan 2016
Venetoclax Receives 3rd Breakthrough Therapy Designation from the FDA for the Combination Treatment of Patients with Untreated Acute Myeloid Leukemia not Eligible for Standard Induction Chemotherapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Jan 2016
AbbVie's Venetoclax Receives Breakthrough Therapy Designation from FDA in Combination with Rituximab for the Treatment of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Jan 2016
ACADIA Pharmaceuticals Appoints Jim Daly to Board of Directors
Biopharmaceuticals Neurology Personnel
 HSMN NewsFeed - 29 Dec 2015
Amarantus Requests Rare Pediatric Disease and Orphan Drug Designations from US FDA for Engineered Skin Substitute in the Treatment of Giant Congenital Melanocytic Nevi
Devices Regenerative Medicine Dermatology FDA
 HSMN NewsFeed - 11 Dec 2015
Cardiorentis' Ularitide Receives FDA Fast Track Designation for the Treatment of Acute Decompensated Heart Failure
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 24 Nov 2015
European Commission Approves Amgen's BLINCYTO(R) (blinatumomab) for the Treatment of Adults with Philadelphia Chromosome-Negative Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 28 Sep 2015
AbbVie's VIEKIRAX(R) (ombitasvir/paritaprevir/ritonavir tablets) Receives Approval in Japan for the Treatment of Genotype 1 Chronic Hepatitis C
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 31 Aug 2015
FDA Grants Priority Review for Intercept's Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Aug 2015
Innocoll AG Appoints Rich Fante as Chief Commercial Officer and Head of Business Development
Biopharmaceuticals Personnel
 HSMN NewsFeed - 6 Jul 2015
Strensiq(R) (asfotase alfa) Receives Marketing Approval in Japan for Treatment of Patients with Hypophosphatasia (HPP)
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 11 May 2015
FDA Grants Priority Review Status for Novocure’s PMA Supplement Application of Optune in Newly Diagnosed Glioblastoma
Devices Oncology FDA
 HSMN NewsFeed - 10 Apr 2015
Horizon Pharma plc Receives FDA Fast Track Designation for ACTIMMUNE(R) in the Treatment of Friedreich's Ataxia
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 18 Mar 2015
U.S. Food and Drug Administration Approves Cholbam for the Treatment of Rare Bile Acid Synthesis Disorders and Grants Rare Pediatric Disease Priority Review Voucher
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Feb 2015
FDA Grants Genentech’s Cobimetinib Priority Review for Use in Combination with Zelboraf (Vemurafenib) in Advanced Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 3 Feb 2015
U.S. FDA Grants Priority Review for YONDELIS(R) (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 26 Jan 2015
Regeneron and Sanofi Announce Praluent(TM) (alirocumab) Biologics License Application has Been Accepted for Priority Review by US FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Aug 2014
Ligand Partner GlaxoSmithKline Receives U.S. FDA Approval for Promacta(R)/Revolade(TM) For Use in Patients with Severe Aplastic Anemia
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Aug 2014
European Commission Approves Bristol-Myers Squibb’s Daklinza (daclatasvir) Across Multiple Genotypes for the Treatment of Chronic Hepatitis C Infection
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 23 Jul 2014
FDA Approves Eagle Pharmaceuticals’ Ryanodex(R) for the Treatment of Malignant Hyperthermia
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Jul 2014
FDA Grants Genentech’s Avastin Priority Review for Recurrent Platinum-Resistant Ovarian Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 Jul 2014
FDA Grants Genentech’s Avastin Priority Review for Certain Types of Cervical Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Jun 2014
Bristol-Myers Squibb Receives Positive CHMP Opinion for Daklinza(R) (daclatasvir) for Treatment of Chronic Hepatitis C in the European Union
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 12 Jun 2014
FDA approves Bayer's Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the United States
Biopharmaceuticals Radiology FDA
 HSMN NewsFeed - 11 Jun 2014
Navidea Biopharmaceuticals’ Lymphoseek(R) (technetium Tc 99m tilmanocept) Injection Demonstrates Preferential Accumulation in Tumor-Positive Sentinel Lymph Nodes in Post-Hoc Analysis
Biopharmaceuticals Oncology
 HSMN NewsFeed - 5 Jun 2014
ORBACTIV(TM) (Oritavancin) Phase 3 Trial Results Published in New England Journal of Medicine
Biopharmaceuticals
 HSMN NewsFeed - 9 May 2014
Prima BioMed's CVac(TM) Granted Fast Track Designation by FDA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 May 2014
FDA Approves Conversion of Soliris(R) (eculizumab) Accelerated Approval in aHUS to Regular Approval for the Treatment of Patients with aHUS
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Feb 2014
InterMune Reports Phase 3 ASCEND Trial Results of Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF)
Biopharmaceuticals
 HSMN NewsFeed - 6 Feb 2014
Spectrum Pharmaceuticals Announces FDA’s Acceptance of NDA Filing for Beleodaq(TM) (belinostat) for Injection, a novel pan-HDAC inhibitor
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Jan 2014
Peregrine Pharmaceuticals Receives FDA Fast Track Designation for Its Immunotherapy Bavituximab as a Potential Treatment of Second-Line Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Dec 2013
Cubist Announces FDA Acceptance of Tedizolid New Drug Application with Priority Review
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Dec 2013
FDA Grants Priority Review for Genzyme’s Cerdelga(TM) (eliglustat), an Investigational Oral Therapy for Gaucher Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Dec 2013
FDA Advisory Committee Recommends Approval of Takeda's Investigational Biologic Vedolizumab
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 6 Dec 2013
U.S. Food and Drug Administration Approves Gilead’s Sovaldi(TM) (Sofosbuvir) for the Treatment of Chronic Hepatitis C
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Nov 2013
U.S. Food and Drug Administration (FDA) Extends Review of Mallinckrodt’s New Drug Application for XARTEMIS(TM) XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Nov 2013
Merck’s New Drug Application for an Investigational Intravenous (IV) Formulation of NOXAFIL(R) (posaconazole) Receives FDA Priority Review
Biopharmaceuticals FDA Regulatory
 HSMN NewsFeed - 23 Oct 2013
FDA Grants Lilly's Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Sep 2013
U.S. Food and Drug Administration Approves ABRAXANE(R) in Combination with Gemcitabine as First-Line Treatment of Patients with Metastatic Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 3 Jul 2013
FDA Grants Genentech’s Obinutuzumab (GA101) Priority Review for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Jul 2013
FDA Grants Genentech’s Perjeta Regimen Priority Review for Use Before Surgery in HER2-Positive Early Stage Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Jun 2013
FDA Approves Amgen's XGEVA(R) (denosumab) For The Treatment Of Giant Cell Tumor Of Bone
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 May 2013
Curis Announces Approval of Erivedge(R) in Australia
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 26 Apr 2013
Curis Announces Erivedge(R) Receives Positive CHMP Opinion for Conditional Approval in European Union
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 28 Feb 2013
FDA Grants QIDP and Fast Track Designations for Cubist’s Late-Stage Antibiotic Candidates
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Feb 2013
ZALTRAP(R) (ziv-aflibercept) Approved in the EU for Patients with Previously Treated Metastatic Colorectal Cancer
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 29 Jan 2013
FDA Grants Soligenix Fast Track Designation for OrbeShield(TM) for the Reduction of Mortality Associated with Gastrointestinal Acute Radiation Syndrome (GI ARS)
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Dec 2012
Titan Pharmaceuticals Licenses Exclusive Probuphine(R) Commercialization Rights in U.S. and Canada to Braeburn Pharmaceuticals
Biopharmaceuticals Drug Delivery Licensing
 HSMN NewsFeed - 17 Dec 2012
Lexicon's Drug Candidate For Irritable Bowel Syndrome Receives Fast Track Status From The FDA
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 29 Nov 2012
Rib-X Pharmaceuticals Closes First Tranche in $67.5 Million Financing
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 20 Nov 2012
Ipsen and Inspiration Biopharmaceuticals Announce That OBI-1 Has Received Fast Track Designation from FDA for Acquired Hemophilia A
Biopharmaceuticals
 HSMN NewsFeed - 29 Oct 2012
Bayer's Stivarga(R) (regorafenib) Tablets New Drug Application Granted Priority Review by U.S. FDA for the Treatment of Patients with Gastrointestinal Stromal Tumors
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Sep 2012
Bayer's Stivarga(R) (regorafenib) Tablets Approved by U.S. FDA for Treatment of Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Sep 2012
Sarepta Therapeutics' Lead Therapeutic Drugs for Ebola and Marburg Viruses Receive FDA Fast Track Designation
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Sep 2012
Alvine Pharmaceuticals’ ALV003 Receives Fast Track Designation From the FDA for the Potential Treatment of Celiac Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Aug 2012
U.S. FDA Grants Priority Review of ZYTIGA(R) (abiraterone acetate) sNDA for Treatment of Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Jun 2012
FDA Approves Lyrica For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Jun 2012
Tokai Pharmaceuticals’ Galeterone Receives Fast Track Designation from the FDA for the Treatment of Advanced Prostate Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 May 2012
FDA Grants Fast Track Designation to Ohr Pharmaceutical's Squalamine Eye Drops for the Treatment of Wet-AMD
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 17 Apr 2012
ThromboGenics Resubmits BLA for Ocriplasmin With the FDA
Biopharmaceuticals Ophthalmology
 HSMN NewsFeed - 5 Apr 2012
Sanofi and Regeneron Announce Regulatory and Clinical Update for ZALTRAP(R) (aflibercept)
Biopharmaceuticals
 HSMN NewsFeed - 1 Feb 2012
FDA approves Novartis drug Gleevec(R) label recommending extending treatment to three years for certain GIST patients after surgery
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 Nov 2011
Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADA(TM*)) in Multiple Sclerosis
Biopharmaceuticals Neurology
 HSMN NewsFeed - 9 Nov 2011
FDA Accepts Genentech’s New Drug Application For Vismodegib in Advanced Form of Skin Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 31 Oct 2011
NeurogesX Appoints Dr. Stephen J. Peroutka as Executive Vice President and Chief Medical Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 15 Jul 2011
XGEVA(R) (Denosumab) Granted Marketing Authorization in the European Union
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 17 Jun 2011
Seattle Genetics Announces Promotion of Eric Dobmeier to Chief Operating Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 20 May 2011
Amgen Receives CHMP Positive Opinion for XGEVA (Denosumab) in the European Union
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 17 May 2011
Pfizer Announces Simultaneous Filing Of New Drug Applications For Crizotinib With U.S. Food And Drug Administration And Japanese Ministry Of Health, Labour And Welfare
Biopharmaceuticals Oncology
 HSMN NewsFeed - 10 May 2011
Columbia Laboratories Appoints Kip Martin as Vice President, Business Development
Biopharmaceuticals Personnel
 HSMN NewsFeed - 3 May 2011
Optimer Pharmaceuticals Expands Senior Management Team
Biopharmaceuticals Personnel
 HSMN NewsFeed - 18 Apr 2011
FDA Grants Priority Review for VEGF Trap-Eye for the Treatment of Wet Age-Related Macular Degeneration
Biopharmaceuticals Ophthalmology
 HSMN NewsFeed - 7 Apr 2011
Alexion Submits Applications for Soliris(R) (Eculizumab) as a Treatment for Patients with Atypical Hemolytic Uremic Syndrome (aHUS) in the United States and European Union
Biopharmaceuticals
 HSMN NewsFeed - 14 Feb 2011
Optimer Pharmaceuticals Appoints Glenn Tillotson, Ph.D., to Senior Vice President of Medical Affairs and Announces Executive Promotions
Biopharmaceuticals Personnel
 HSMN NewsFeed - 24 Jan 2011
Furiex Receives FDA Fast Track Designation of MuDelta for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 22 Dec 2010
Delcath Completes New Drug Application Submission to the FDA for the Chemosaturation Delivery System
Biopharmaceuticals Devices Drug Delivery Oncology FDA
 HSMN NewsFeed - 22 Dec 2010
FDA Issues Complete Response Letter Regarding Acetadote(R) Supplemental New Drug Application for Acute Liver Failure
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Dec 2010
US FDA Advisory Committee Makes Recommendation on New Drug Application for Vandetanib in Advanced Medullary Thyroid Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Oct 2010
Novartis Drug Afinitor(R) Approved by FDA as First Medication for Children and Adults with a Benign Brain Tumor Associated with Tuberous Sclerosis
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 1 Oct 2010
Phase III Data Showing Improved Survival With Jevtana(R) (cabazitaxel) Injection in Second-Line Advanced Prostate Cancer Published in The Lancet
Biopharmaceuticals Oncology
 HSMN NewsFeed - 19 Aug 2010
Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for BENLYSTA(R) (belimumab) as a Potential Treatment for Systemic Lupus Erythematosus
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Aug 2010
Ipilimumab Receives FDA Priority Review Designation for Adult Patients with Previously Treated Advanced Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Jun 2010
Salix Pharmaceuticals Announces NDA Submission For XIFAXAN550 For Treatment of Non-Constipation Irritable Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 4 Jun 2010
New Data at ASCO Show Novartis Drug Tasigna(R) Surpasses Gleevec(R) for Newly Diagnosed CML Patients
Biopharmaceuticals Oncology
 HSMN NewsFeed - 10 May 2010
Ferring Acquires LYSTEDA(TM) From Xanodyne Pharmaceuticals, Inc.
Biopharmaceuticals Acquisitions
 HSMN NewsFeed - 16 Apr 2010
Alexion's Soliris(R) (Eculizumab) Receives Marketing Approval in Japan for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 6 Apr 2010
Allon Therapeutics Announces Davunetide Receives FDA Fast Track Status for Treatment of Progressive Supranuclear Palsy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 6 Apr 2010
Genta's Tesetaxel Granted Fast Track Designation by FDA for Advanced Gastric Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 Apr 2010
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Refractory Advanced Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Mar 2010
InterMune Announces Submission of MAA for Pirfenidone for the Treatment of Patients With IPF
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 22 Feb 2010
FDA Acknowledges Need for Daily Multiple Sclerosis Pill by Granting Fingolimod Priority Review Status
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 19 Feb 2010
Novartis Drug Tasigna(R) Receives FDA Priority Review for Newly Diagnosed Patients With Early-Stage Chronic Myeloid Leukemia
Biopharmaceuticals Oncology
 HSMN NewsFeed - 31 Dec 2009
Photocure Received Positive Response From FDA on the New Drug Application (NDA) for Hexvix(R) for Detection of Bladder Cancer
Biopharmaceuticals Diagnostics Oncology FDA
 HSMN NewsFeed - 30 Dec 2009
Pfizer Provides U.S. Regulatory Update On Prevnar 13 Vaccine
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Dec 2009
Shire Submits Biologics License Application (BLA) for REPLAGAL(R) With the U.S. Food and Drug Administration (FDA)
Biopharmaceuticals
 HSMN NewsFeed - 17 Dec 2009
Medivation Announces Organizational Changes to Support Anticipated Growth and Future Commercialization
Biopharmaceuticals Personnel
 HSMN NewsFeed - 2 Dec 2009
AEterna Zentaris' Anti-Cancer Compound, Perifosine (KRX-0401), Receives FDA Fast Track Designation for the Treatment of Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Dec 2009
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Nov 2009
ARCA Receives FDA Fast Track Designation for Gencaro(TM) Development in Genotype-Defined Heart Failure Population
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 19 Oct 2009
Lux Biosciences Completes $50 Million Series B Financing
Biopharmaceuticals Ophthalmology Venture Capital
 HSMN NewsFeed - 24 Sep 2009
Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Sep 2009
FDA Grants Priority Review Status to Supplement Containing Long-Term Survival Data for VELCADE(R) (bortezomib) for Injection
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Sep 2009
FDA Grants Protalix Orphan Drug Designation for prGCD
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Jul 2009
Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Jul 2009
Biogen Idec and Acorda Therapeutics Announce Collaboration Agreement to Develop and Commercialize MS Therapy Fampridine-SR in Markets Outside the U.S.
Biopharmaceuticals Neurology Licensing
 HSMN NewsFeed - 29 Jun 2009
Teva and Antares Announce FDA Approval of Needle-Free Injector Product for Administration of Tev-Tropin(R) (Human Growth Hormone)
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 17 Jun 2009
Epeius Biotechnologies' Rexin-G Receives FDA Fast Track Designation for the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 May 2009
Pixantrone Now Available in Europe on a Named-Patient Basis
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 28 Apr 2009
XIAFLEX(TM) for the Treatment of Dupuytren's Contracture Receives Priority Review From the U.S. Food and Drug Administration
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Apr 2009
Xanodyne's New Drug Application for the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Apr 2009
Alexion Submits NDA in Japan for Soliris(R) (eculizumab) as a Treatment for Patients with PNH
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 30 Mar 2009
Seattle Genetics Receives FDA Fast Track Designation for SGN-35 for the Treatment of Hodgkin Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Mar 2009
FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 16 Mar 2009
Spectrum Pharmaceuticals Acquires 100% of ZEVALIN, an FDA-Approved, Proprietary, Biological Drug for Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology Acquisitions
 HSMN NewsFeed - 2 Mar 2009
ImClone Systems and Bristol-Myers Squibb Update Status of First-Line Squamous Cell Carcinoma of the Head and Neck Supplemental Biologics Application for ERBITUX(R) in U.S.
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Feb 2009
Spectrum Pharmaceuticals Poised to Acquire 100% Interest in RIT Oncology LLC Joint Venture upon CTI's Fulfillment of Closing Conditions
Biopharmaceuticals Oncology Acquisitions
 HSMN NewsFeed - 18 Feb 2009
Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 11 Feb 2009
New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq(R) (dronedarone) in Atrial Fibrillation
Biopharmaceuticals Cardiology
 HSMN NewsFeed - 10 Feb 2009
Dyax and Fovea Sign Development and Commercialization Agreement for DX-88 in Ophthalmic Indications
Biopharmaceuticals Ophthalmology
 HSMN NewsFeed - 5 Feb 2009
Immunomedics' hPAM4 Labeled With Yttrium-90 Receives Fast Track Designation From FDA for Therapy of Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Feb 2009
FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Feb 2009
FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Jan 2009
Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Jan 2009
Pixantrone Pre-NDA Communication from FDA Provides Cell Therapeutics Basis to Begin Rolling NDA Submission
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 17 Jan 2009
CSL Behring Receives FDA Approval of RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Jan 2009
Osiris and FDA Reach Agreement on Submission of First Marketing Application for a Stem Cell Product
Regenerative Medicine FDA
 HSMN NewsFeed - 6 Jan 2009
DOR BioPharma Obtains Fast Track Designation for DOR201 in the Prevention of Acute Radiation Enteritis
Biopharmaceuticals
 HSMN NewsFeed - 2 Jan 2009
New Drug Application Submitted For Acurox(r) Tablets
Biopharmaceuticals
 HSMN NewsFeed - 16 Dec 2008
Cell Therapeutics and Spectrum Pharmaceuticals Close Transaction Forming Joint Venture to Market Zevalin in the US
Biopharmaceuticals Oncology
 HSMN NewsFeed - 1 Dec 2008
FDA Accepts Cell Therapeutics' Zevalin sBLA and Grants Priority Review
Biopharmaceuticals Oncology
 HSMN NewsFeed - 24 Nov 2008
King Pharmaceuticals To Acquire Alpharma for Approximately $1.6 Billion
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 11 Nov 2008
Study Finds Catheter Ablation with the NAVISTAR(R) THERMOCOOL(R) Catheter Superior to Anti-Arrhythmic Drug Therapy for the Treatment of Symptomatic, Paroxysmal Atrial Fibrillation
Devices Cardiology
 HSMN NewsFeed - 31 Oct 2008
Savient Submits Biologics License Application (BLA) for pegloticase
Biopharmaceuticals
 HSMN NewsFeed - 19 Sep 2008
FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults
Biopharmaceuticals Radiology FDA
 HSMN NewsFeed - 12 Sep 2008
King Commences Cash Tender Offer for Alpharma at $37 Per Share
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 3 Sep 2008
ImClone Submits Supplemental Biologics License Application for ERBITUX(R) in First-Line Head and Neck Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 3 Sep 2008
Further Analysis From ATHENA Study Showed That Multaq(R)(Dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation
Biopharmaceuticals Cardiology
 HSMN NewsFeed - 27 Aug 2008
Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Aug 2008
King Proposes Acquisition of Alpharma for $33 Per Share in Cash
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 19 Aug 2008
Pain Therapeutics and King Pharmaceuticals Announce Final Data of REMOXY Phase III Study at World Pain Congress in Scotland
Biopharmaceuticals
 HSMN NewsFeed - 8 Aug 2008
Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 30 Jun 2008
Introgen Submits ADVEXIN(R) Regulatory Applications in the U.S. and Europe
Biopharmaceuticals Oncology FDA Regulatory
 HSMN NewsFeed - 25 Jun 2008
Merck & Co., Inc Receives Complete Response Letter from the Food and Drug Administration for Use of GARDASIL(R) in Women Ages 27 through 45
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Jun 2008
Sirion Therapeutics Announces FDA Approval of Durezol(TM) for Treatment of Postoperative Ocular Inflammation and Pain
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 10 Jun 2008
Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy
Biopharmaceuticals
 HSMN NewsFeed - 6 Jun 2008
US FDA grants pediatric exclusivity for UCB's Keppra(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Jun 2008
Acorda Therapeutics Announces Positive Data from Second Phase 3 Study of Fampridine-SR on Walking Ability in People with Multiple Sclerosis
Biopharmaceuticals Neurology
 HSMN NewsFeed - 31 May 2008
VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multiple Myeloma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 19 May 2008
InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 May 2008
FDA Grants Priority Review of Gamunex(R) as a Treatment for Neurological Disorder CIDP
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Apr 2008
Alpharma to Withdraw and Resubmit Its New Drug Application for EMBEDA(TM)
Biopharmaceuticals
 HSMN NewsFeed - 21 Apr 2008
Genzyme Provides Update on Myozyme(R) Manufacturing
Biopharmaceuticals
 HSMN NewsFeed - 1 Apr 2008
Wyeth and Progenics Announce RELISTOR Receives Canadian Marketing Approval
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 29 Mar 2008
Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel
Biopharmaceuticals Interventional Cardiology
 HSMN NewsFeed - 24 Mar 2008
Corcept Therapeutics Announces Commencement of Next Phase 3 Study With CORLUX(R) for the Treatment of Psychotic Depression
Biopharmaceuticals
 HSMN NewsFeed - 20 Mar 2008
Cephalon Receives FDA Approval for TREANDA, a Novel Chemotherapy for Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 19 Mar 2008
Supplemental Application for GARDASIL(R), Merck's Cervical Cancer Vaccine, Designated Priority Review by the U.S. FDA for Use in Women 27 through 45
Biopharmaceuticals
 HSMN NewsFeed - 11 Mar 2008
FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Mar 2008
FDA Grants Priority Review for PROMACTA(R) (eltrombopag)
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Feb 2008
FDA Accepts for Review OVATION's Two NDA Submissions for Sabril(R)
Biopharmaceuticals Neurology
 HSMN NewsFeed - 20 Feb 2008
New Breakthrough Treatment for Advanced Kidney Cancer Shows 49 Per Cent Higher Survival Rates
Biopharmaceuticals Oncology
 HSMN NewsFeed - 19 Feb 2008
FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 18 Feb 2008
Solvay Pharmaceuticals, Inc. Receives Fast Track Designation From U.S. Food and Drug Administration for Levodopa/Carbidopa Intestinal Gel for Advanced Parkinson's Disease
Biopharmaceuticals FDA Neurology
 HSMN NewsFeed - 31 Jan 2008
FDA Grants Priority Review for Schering-Plough's Peginterferon Alfa-2b for the Adjuvant Treatment of Patients With Stage III Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Jan 2008
Lux Granted Fast Track Designation for LX201 for Corneal Transplant Rejection
Biopharmaceuticals Ophthalmology Drug Delivery FDA
 HSMN NewsFeed - 30 Jan 2008
FDA Grants Priority Review For Velcade(R) (bortezomib) for Injection In Patients with Newly Diagnosed Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Jan 2008
AHF Criticizes Tibotec Over Steep Price for Newest AIDS Drug, Etravirine
Biopharmaceuticals HIV/AIDS
 HSMN NewsFeed - 31 Dec 2007
Cephalon Submits New Drug Application for TREANDA for the Treatment of Patients with Relapsed Indolent Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Dec 2007
Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multiple Myeloma
Biopharmaceuticals FDA Oncology
 HSMN NewsFeed - 13 Dec 2007
Neurologix Gene Therapy Approach to Parkinson's Disease Granted Fast Track Designation From FDA
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 10 Dec 2007
Pivotal Phase 3 NPLATE(TM) Study in Non-Splenectomized Patients Met Primary Endpoints
Biopharmaceuticals
 HSMN NewsFeed - 8 Dec 2007
Pivotal Phase 3 Romiplostim Study in Splenectomized Patients Meets Primary Endpoints
Biopharmaceuticals
 HSMN NewsFeed - 3 Dec 2007
FDA Approves Diovan(R) for Treatment of High Blood Pressure in Children
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Nov 2007
Nexavar First FDA-Approved Drug Therapy for Liver Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 Nov 2007
ABILIFY(R) (aripiprazole) Supplemental New Drug Application for the Treatment of Pediatric Patients with Bipolar I Disorder Accepted for Priority Review by the U.S. Food and Drug Administration
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Nov 2007
FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
Biopharmaceuticals FDA Oncology
 HSMN NewsFeed - 30 Oct 2007
Nexavar Becomes First and Only Approved Treatment of Hepatocellular Carcinoma in Europe
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 29 Oct 2007
Jerini Submits New Drug Application for Icatibant in the Treatment of HAE to the FDA and Requests Priority Review
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Oct 2007
NCCN Updates Multiple Myeloma Guidelines
Biopharmaceuticals Oncology
 HSMN NewsFeed - 10 Oct 2007
Multicenter PolyHeme Trauma Study Presented at the American College of Surgeons 93rd Annual Clinical Congress
Biopharmaceuticals
 HSMN NewsFeed - 28 Sep 2007
CSL Biotherapies announces FDA marketing approval of Afluria(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Sep 2007
Nexavar Receives Positive Opinion from European Committee for Medicinal Products for Human Use for Treatment of Liver Cancer
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 20 Sep 2007
FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 18 Sep 2007
ISENTRESS(TM) (raltegravir), in Combination with Optimized Background Therapy (OBT), Provided Sustained Viral Suppression in Highly Treatment-Experienced Patients Infected with HIV, through 48 Weeks
Biopharmaceuticals HIV/AIDS
 HSMN NewsFeed - 5 Sep 2007
FDA Advisory Committee Unanimously Recommends Accelerated Approval of ISENTRESS(TM) (raltegravir), Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 5 Sep 2007
Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 20 Aug 2007
Nexavar Granted FDA Priority Review for Treatment of Liver Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Aug 2007
ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Aug 2007
Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
Biopharmaceuticals
 HSMN NewsFeed - 10 Aug 2007
FDA Grants Additional Six Months Marketing Exclusivity for the High Blood Pressure Medicine Diovan(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Aug 2007
Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS
Biopharmaceuticals
 HSMN NewsFeed - 7 Aug 2007
Lux Granted Fast Track Designation by FDA for LX211 for the Treatment of Uveitis
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 25 Jul 2007
Kuvan Receives Priority Review Status from FDA
Biopharmaceuticals
 HSMN NewsFeed - 20 Jul 2007
Abbott Submits E.U. and U.S. Regulatory Filings for New Lower-Strength Kaletra(R) and Aluvia(R) (lopinavir/ritonavir) Tablet Suitable for Pediatric Use in HIV/AIDS
Biopharmaceuticals Regulatory HIV/AIDS
 HSMN NewsFeed - 18 Jul 2007
FDA Grants Fast Track Designation to Cardium's Phase 3 Angiogenic Gene Therapy for Heart Disease
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 17 Jul 2007
ABILIFY(R) (aripiprazole) Supplemental New Drug Application Receives Priority Review by U.S. Food And Drug Administration for Adjunctive Treatment in Adults With Major Depressive Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Jul 2007
Study Shows Ixabepilone Demonstrated Clear Activity in Patients with Metastatic Breast Cancer Resistant to Anthracycline, Taxane, and Capecitabine
Biopharmaceuticals Oncology
 HSMN NewsFeed - 27 Jun 2007
Taxotere(R) (docetaxel) Granted FDA Priority Review for Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck Prior to Chemoradiotherapy and Surgery
Biopharmaceuticals FDA Oncology
 HSMN NewsFeed - 27 Jun 2007
FDA Priority Review Granted for ISENTRESS(TM) (raltegravir), Merck's Investigational Integrase Inhibitor for HIV
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 26 Jun 2007
Pharmion Submits European Marketing Authorization Application for Satraplatin in Combination With Prednisone for the Treatment of Patients With Metastatic Hormone-Refractory Prostate Cancer Who Have Failed Prior Chemotherapy
Biopharmaceuticals Oncology
 HSMN NewsFeed - 25 Jun 2007
GPC Biotech Announces Partnering Agreement for Satraplatin for Japan with Yakult
Biopharmaceuticals Oncology Licensing
 HSMN NewsFeed - 21 Jun 2007
Pfizer's Lyrica Receives FDA Approval for Fibromyalgia Based on Expedited Review
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Jun 2007
FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Jun 2007
BioMarin Initiates Expanded Access Program for Kuvan in the U.S.
Biopharmaceuticals
 HSMN NewsFeed - 14 Jun 2007
Shire's ELAPRASE(TM) (idursulfase) Approved by Health Canada for Treatment of Hunter Syndrome
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 11 Jun 2007
Northfield Laboratories Announces New Regulatory Leadership
Biopharmaceuticals Personnel
 HSMN NewsFeed - 11 Jun 2007
FDA Accepts and Grants Priority Review of ERBITUX(R) (Cetuximab) sBLA for Overall Survival in Patients with Advanced Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Jun 2007
Regeneron Submits Biologics License Application to U.S. FDA for IL-1 Trap (Rilonacept) for Treatment of CAPS
Biopharmaceuticals
 HSMN NewsFeed - 4 Jun 2007
Additional New Data from Satraplatin SPARC Phase 3 Investigational Trial Presented at ASCO Annual Meeting
Biopharmaceuticals Oncology
 HSMN NewsFeed - 24 May 2007
BioMarin Submits New Drug Application for U.S. Marketing Authorization of Kuvan for Phenylketonuria (PKU)
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 May 2007
Additional Satraplatin Efficacy Data From Phase 3 SPARC Trial Presented at Annual Meeting of American Urological Association
Biopharmaceuticals Oncology Urology
 HSMN NewsFeed - 21 May 2007
Gilead Announces Presentation of Long-Term Data for Ambrisentan, a Potential Treatment for Patients With Pulmonary Arterial Hypertension
Biopharmaceuticals
 HSMN NewsFeed - 21 May 2007
U.S. FDA Approves VELCADE(R) + DOXIL(R) Combination for Treatment of Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 20 May 2007
Pfizer Says Research and Development Head John LaMattina Will Retire This Year
Biopharmaceuticals Personnel
 HSMN NewsFeed - 16 May 2007
Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 May 2007
Spectrum Pharmaceuticals Announces FDA'S Oncology Drug Advisory Committee to Review Satraplatin for the Treatment of Hormone Refractory Prostate Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 27 Apr 2007
Abbott's HUMIRA(R) (Adalimumab) Receives Positive Opinion from European Medicines Agency for the Treatment of Crohn's Disease
Biopharmaceuticals Gastroenterology Regulatory
 HSMN NewsFeed - 16 Apr 2007
FDA Accepts Satraplatin NDA And Grants Priority Review
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Apr 2007
FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status
Biopharmaceuticals Oncology
 HSMN NewsFeed - 6 Apr 2007
Wyeth Provides Update on FDA Review of the Torisel New Drug Application
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Mar 2007
Northfield Laboratories Names New Vice President Finance
Biopharmaceuticals Personnel
 HSMN NewsFeed - 13 Mar 2007
FDA Approves TYKERB(R) (lapatinib) in Combination With Xeloda(R) (capecitabine) for the Treatment of Advanced or Metastatic Breast Cancer in Women Who Have Progressed on Prior Therapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Feb 2007
GPC Biotech Submits NDA for Lead Oncology Drug Candidate Satraplatin
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Feb 2007
Spectrum Pharmaceuticals Announces Completion of NDA Filing for Satraplatin for Hormone Refractory Prostate Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Feb 2007
Pfizer's Maraviroc to Receive Accelerated Regulatory Reviews in the U.S. and Europe
Biopharmaceuticals Regulatory HIV/AIDS
 HSMN NewsFeed - 7 Feb 2007
FDA Grants Priority Review to Lovenox(R) (Enoxaparin Sodium Injection) Supplemental New Drug Application (sNDA) for Acute Heart Attack
Biopharmaceuticals Cardiology
 HSMN NewsFeed - 7 Feb 2007
ViroPharma Receives Orphan Drug Designation for Maribavir for Cytomegalovirus Viremia and Disease Indication
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Feb 2007
GlaxoSmithKline Receives Approvable Letter for New Indications for ARIXTRA(R) (Fondaparinux Sodium) Injection
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 16 Jan 2007
Merck Serono Completes Patient Enrollment in CLARITY Phase III Pivotal Clinical Trial of Oral Cladribine
Biopharmaceuticals Neurology
 HSMN NewsFeed - 8 Jan 2007
Interim Safety Analysis Supports Continuation of Allos Therapeutics' Pivotal Phase 2 Trial of Its Novel Antifolate PDX in Patients With Peripheral T-cell Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 19 Dec 2006
Northfield Laboratories Reports Preliminary Top-Line Data in Pivotal Phase III Trauma Study
Biopharmaceuticals
 HSMN NewsFeed - 19 Dec 2006
FDA Grants Torisel NDA Priority Review Status
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Dec 2006
Eculizumab is Well Tolerated and Demonstrates Significant Improvement During 52 Weeks of Treatment in Open-Label Phase III SHEPHERD Study in PNH Patients
Biopharmaceuticals
 HSMN NewsFeed - 4 Dec 2006
Publications Feature VELCADE(R) (Bortezomib) for Injection Strength In Hematological Cancers
Biopharmaceuticals Oncology
 HSMN NewsFeed - 15 Nov 2006
Synta Pharmaceuticals Announces FDA Fast Track Designation for STA-4783 in Metastatic Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 Nov 2006
FDA Grants Priority Review for Soliris(TM) (eculizumab) BLA for Treatment of Paroxysmal Nocturnal Hemoglobinuria
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Oct 2006
Abbott's HUMIRA(R) (Adalimumab) Granted FDA Priority Review for the Treatment of Moderately to Severely Active Crohn's Disease
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 26 Oct 2006
IDM Pharma Submits New Drug Application to the FDA for Junovan(TM) (mifamurtide) in the Treatment of Osteosarcoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 26 Oct 2006
Millennium and Ortho Biotech Enter into U.S. Co-Promotion Agreement for VELCADE(R)(bortezomib) for Injection
Biopharmaceuticals Oncology
 HSMN NewsFeed - 18 Oct 2006
Taxotere(R) Receives U.S. FDA Approval for the Treatment of Patients With Head and Neck Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Oct 2006
Journal of Clinical Oncology Publishes Final Study Results of VELCADE(R) (Bortezomib) for Injection in Relapsed Mantle Cell Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 4 Oct 2006
Arixtra(R) Receives Priority Review by the FDA in Acute Coronary Syndromes (ACS)
Biopharmaceuticals Cardiology Generics
 HSMN NewsFeed - 3 Oct 2006
Allos Therapeutics Receives FDA Fast Track Designation for PDX for the Treatment of T-cell Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Oct 2006
FDA Grants Priority Review for ARIXTRA(R) (fondaparinux sodium) in the Treatment of Acute Coronary Syndromes
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 29 Sep 2006
FDA Approves Two New Indications for Rituxan(R) in Patients With Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Sep 2006
Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of Diabetic Retinopathy
Biopharmaceuticals FDA Ophthalmology
 HSMN NewsFeed - 27 Sep 2006
FDA Approves Vectibix(TM) to Treat Patients with Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 26 Sep 2006
Millennium Agrees to Acquire AnorMED, Adding Phase III Oncology Product with Planned Near Term Launch Date
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 22 Sep 2006
DOR BioPharma Files New Drug Application with FDA to Market orBec for GI GVHD
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Sep 2006
Serono's Oral Cladribine for the Treatment of Multiple Sclerosis Awarded Fast Track Status by FDA
Biopharmaceuticals FDA Neurology
 HSMN NewsFeed - 17 Jul 2006
Wyeth and Progenics Announce Methylnaltrexone Receives FDA Fast Track Designation for Treatment of Postoperative Ileus
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Jul 2006
FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Jun 2006
FDA Approves LUCENTIS for the Treatment of Wet Age-Related Macular Degeneration
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 2 Jun 2006
Bristol-Myers Squibb Issues Statement on Oncologic Drugs Advisory Committee Vote in Favor of Investigational Drug Dasatinib
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 May 2006
Genentech Submits Supplemental Biologics License Application for Avastin With Chemotherapy in First-Line Metastatic Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 May 2006
AVANIR Completes the Acquisition of Alamo Pharmaceuticals
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 23 May 2006
AVANIR Announces the Intended Acquisition of a Private Specialty Pharmaceutical Company
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 16 May 2006
Marshall Edwards Achieves Special Protocol Assessment and Agreement With FDA on Phase III (Ovature Study) of Phenoxodiol as a Chemosensitizing Agent in Women With Platinum-Resistant Ovarian Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 May 2006
Pfizer's Smoking Cessation Medicine Chantix(TM) (Varenicline) Receives FDA Approval
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 May 2006
AVANIR Pharmaceuticals Hires Michael J. Puntoriero to Serve as Senior Vice President of Finance and Chief Financial Officer
Biopharmaceuticals Personnel
Return to NewsFeed  

 Additional items found! 278

Members: click here for search results from The HSMN Archive (password required)
Members Archive contains 278 additional stories matching:
Priority Review
(Password required)
FindReps - screen and connect with rep candidates anonymously, in real time.

FindReps: Screen and connect with Medical Sales Rep candidates (Direct Reps and Independents) – anonymously, in real time.


RepJobs - Job Opportunities for Direct Sales Reps and New Product Lines for Independents!

RepJobs: Job Opportunities for Direct Sales Reps and New Product Lines for Independents!