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Searching News Database:  Breakthrough Therapy designation 

 HSMN NewsFeed - 16 Jul 2026
Lilly to Acquire AtaiBeckley to Advance Therapies for Treatment-Resistant Depression and Other Mental Health Conditions
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 11 May 2026
Partner Therapeutics Announces FDA Approval of BIZENGRI(R) (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner's National Priority Voucher
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Mar 2026
Otsuka Pharmaceutical to Acquire Transcend Therapeutics
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 29 Dec 2025
FDA Accepts for Review INOVIO's BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP)
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Sep 2025
Servier and IDEAYA Biosciences Partner to Bring Darovasertib, a Promising Uveal Melanoma Treatment, to Patients Worldwide
Biopharmaceuticals Oncology Licensing
 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 - 15 Jan 2025
New Drug Application Initiated with U.S. FDA for TAR-200, the First and Only Intravesical Drug Releasing System for Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer
Biopharmaceuticals Drug Delivery 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 - 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 - 19 Jun 2024
European Commission grants Sobi(R) Marketing Authorisation for ALTUVOCT(TM) for treatment of haemophilia A
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 26 Apr 2024
Sobi(R) Receives Positive CHMP Opinion Recommending Approval of Efanesoctocog Alfa for Once-Weekly Treatment of Haemophilia A
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 27 Feb 2024
Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-520
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Feb 2024
AbbVie Completes Acquisition of ImmunoGen
Biopharmaceuticals Oncology Mergers & Acquisitions
 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 - 7 Aug 2023
NRx Pharmaceuticals Announces the Licensure of a US Patent to Support Use of NRX-101(TM) for Chronic Pain
Biopharmaceuticals Licensing
 HSMN NewsFeed - 18 Jul 2023
Renibus Therapeutics Announces $47 Million Financing to Advance Lead Program RBT-1 Through Pivotal Phase 3 Trial
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 6 Jan 2023
Aeglea BioTherapeutics Announces Update to Corporate Structure to Increase Operational Efficiency
Biopharmaceuticals Personnel
 HSMN NewsFeed - 9 Dec 2022
Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 Dec 2022
NRx Pharmaceuticals Announces the Appointment of Carrie M. Carretta, PhD, APN-BC, AHN-BC, PMHNP, Senior Vice President of Clinical Development and Medical Affairs
Biopharmaceuticals Neurology Personnel
 HSMN NewsFeed - 30 Nov 2022
Aeglea BioTherapeutics Appoints Jeffrey M. Goldberg as Chief Executive Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 23 Nov 2022
BioMarin Announces Advancements in FDA Review of ROCTAVIAN(TM) (Valoctocogene Roxaparvovec) for Adults with Severe Hemophilia A
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Aug 2022
Aeglea BioTherapeutics Announces Leadership Transition and Corporate Restructuring
Biopharmaceuticals Personnel
 HSMN NewsFeed - 18 Mar 2022
NRx Pharmaceuticals, Inc. Appoints Ira Strassberg as Chief Financial Officer and Treasurer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 28 Jan 2022
Blueprint Medicines' AYVAKYT(R) (avapritinib) Receives Positive CHMP Opinion for the Treatment of Adults with Advanced Systemic Mastocytosis
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 14 Dec 2021
MindMed Appoints Robert Barrow as Chief Executive Officer and Director
Biopharmaceuticals Personnel
 HSMN NewsFeed - 20 Oct 2021
vTv Therapeutics Announces Deepa Prasad as New President and CEO
Biopharmaceuticals Personnel
 HSMN NewsFeed - 30 Sep 2021
OLUMIANT(R) Significantly Improved Hair Regrowth to At Least 80% Scalp Coverage as Early as 24 Weeks Across First Completed Phase 3 Studies for Alopecia Areata
Biopharmaceuticals
 HSMN NewsFeed - 17 Aug 2021
Lilly Announces Leadership Changes and Formation of Neuroscience and Immunology Business Units
Biopharmaceuticals Personnel
 HSMN NewsFeed - 6 Aug 2021
FDA Approves New Treatment for Pompe Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Jul 2021
Aeglea BioTherapeutics Appoints Jim Kastenmayer as General Counsel
Biopharmaceuticals Personnel
 HSMN NewsFeed - 24 Jun 2021
Lilly's donanemab receives U.S. FDA's Breakthrough Therapy designation for treatment of Alzheimer's disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 9 Jun 2021
MindMed Announces Chief Executive Officer Transition
Biopharmaceuticals Personnel
 HSMN NewsFeed - 1 Jun 2021
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 May 2021
FDA Grants Bold Therapeutics' BOLD-100 an Orphan Drug Designation (ODD) in the Treatment of Gastric Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Apr 2021
Lilly and Incyte's Baricitinib Improved Hair Regrowth for Alopecia Areata Patients in Second Phase 3 Study
Biopharmaceuticals
 HSMN NewsFeed - 1 Apr 2021
FDA Grants Breakthrough Therapy Designation for Taiho Oncology's Futibatinib for Treatment of Advanced Cholangiocarcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Mar 2021
BioMarin Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Valoctocogene Roxaparvovec, Investigational Gene Therapy for Hemophilia A
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Mar 2021
Merck KGaA, Darmstadt, Germany, Builds on Leadership in Head and Neck Cancer Through Worldwide Licensing Agreement with Debiopharm for Pivotal-Stage Xevinapant
Biopharmaceuticals Oncology Licensing
 HSMN NewsFeed - 22 Dec 2020
Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma
Biopharmaceuticals
 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 - 8 Dec 2020
Amgen's Sotorasib Granted Breakthrough Therapy Designation for Advanced or Metastatic Non-Small Cell Lung Cancer Patients with KRAS G12C Mutation
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Nov 2020
Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma
Biopharmaceuticals
 HSMN NewsFeed - 12 Oct 2020
OncoSec Announces Appointment of Sandra Aung, Ph.D. as Senior Vice President, Chief Clinical Development Officer
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 25 Sep 2020
Blueprint Medicines Announces European Commission Approval of AYVAKYT(R) (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA D842V Mutant Gastrointestinal Stromal Tumors
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 21 Sep 2020
Relief and NeuroRx Announce Partnership for Global Commercialization of RLF-100(TM) and Selection of Commercial Partners
Biopharmaceuticals
 HSMN NewsFeed - 9 Sep 2020
Phosplatin Therapeutics Announces Two Leadership Appointments
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 1 Sep 2020
Blueprint Medicines Strengthens Leadership with Appointment of Fouad Namouni, M.D., as President, Research & Development
Biopharmaceuticals Personnel
 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 - 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 - 6 Aug 2020
FDA grants inhaled use IND for RLF-100 (aviptadil) to treat patients with moderate and severe COVID-19 aiming to prevent progression to respiratory failure
Biopharmaceuticals Drug Delivery 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 - 15 May 2020
Blueprint Medicines Receives Complete Response Letter from FDA for Avapritinib New Drug Application for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 Apr 2020
Blueprint Medicines Announces Top-line Results from Phase 3 VOYAGER Trial of Avapritinib versus Regorafenib in Patients with Advanced Gastrointestinal Stromal Tumor
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 - 9 Apr 2020
EMD Serono and Pfizer Receive US FDA Breakthrough Therapy Designation and Submit Application for BAVENCIO(R) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Apr 2020
Blueprint Medicines Announces the Achievement of Key Portfolio Milestones
Biopharmaceuticals Oncology
 HSMN NewsFeed - 16 Mar 2020
Lilly Receives FDA Breakthrough Therapy Designation for Baricitinib for the Treatment of Alopecia Areata
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Feb 2020
Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for PADCEV(TM) (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder 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 - 17 Jan 2020
PANTHERx(R) Rare Pharmacy Selected by Blueprint Medicines Corporation to Distribute AYVAKIT(TM) (avapritinib) for Genomically Defined Patient Population with Rare Cancer, GIST
Biopharmaceuticals Oncology Distribution
 HSMN NewsFeed - 8 Jan 2020
Provention Bio Appoints Jason Hoitt as Chief Commercial Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 23 Dec 2019
European Medicines Agency Validates BioMarin's Marketing Authorization Application for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 11 Nov 2019
AI Medical Service Inc. announces FDA Breakthrough Device Designation for endoscopic AI system
Devices Gastroenterology FDA
 HSMN NewsFeed - 8 Nov 2019
Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA(R) (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Oct 2019
Provention Bio Announces PRV-031 (Teplizumab) Granted PRIME Designation by the European Medicines Agency
Biopharmaceuticals Endocrinology Regulatory
 HSMN NewsFeed - 23 Oct 2019
NeuroRx Secures HK$ 750 Million Capital Commitment From The Gem Group for Development of NRX-101
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 10 Oct 2019
FDA Grants Ofev(R) Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype
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 - 11 Sep 2019
Merck KGaA, Darmstadt, Germany, Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations
Biopharmaceuticals Oncology
 HSMN NewsFeed - 9 Sep 2019
Lilly Announces Positive Results for Selpercatinib (LOXO-292), Demonstrating a 68 Percent Objective Response Rate and Sustained Durability in Heavily Pretreated RET Fusion-Positive Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 20 Aug 2019
Eiger Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Aug 2019
Regeneron Announces Positive Topline Results from Phase 3 Trial of Evinacumab in Patients with Severe, Inherited Form of High Cholesterol
Biopharmaceuticals Cardiology
 HSMN NewsFeed - 1 Aug 2019
Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo(R) (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 31 May 2019
Iovance Biotherapeutics Expands Partnership with WuXi Advanced Therapies Business
Biopharmaceuticals Oncology
 HSMN NewsFeed - 28 May 2019
BioMarin Announces that Phase 3 Cohort of Valoctocogene Roxaparvovec, Gene Therapy Study in Severe Hemophilia A Met Pre-Specified Criteria for Regulatory Submissions in the U.S. and Europe
Biopharmaceuticals
 HSMN NewsFeed - 8 May 2019
Daiichi Sankyo Announces [Fam-] Trastuzumab Deruxtecan Demonstrated Clinically Meaningful Response in Patients with Refractory HER2 Positive Metastatic Breast Cancer, a Population with High Unmet Need
Biopharmaceuticals Oncology
 HSMN NewsFeed - 28 Mar 2019
Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer
Biopharmaceuticals Urology Oncology
 HSMN NewsFeed - 15 Feb 2019
Lilly Completes Acquisition of Loxo Oncology
Biopharmaceuticals Oncology Mergers & Acquisitions
 HSMN NewsFeed - 28 Jan 2019
U.S. FDA Approves IMBRUVICA(R) (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 Jan 2019
Daiichi Sankyo Initiates Pivotal Phase 3 Trial of [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Low Metastatic Breast Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 7 Jan 2019
Lilly Announces Agreement To Acquire Loxo Oncology
Biopharmaceuticals Oncology Mergers & Acquisitions
 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 - 19 Dec 2018
Eiger Announces Breakthrough Therapy Designation Granted by FDA for Lonafarnib in Progeria and Progeroid Laminopathies
Biopharmaceuticals 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 - 14 Nov 2018
Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality(TM) (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 5 Nov 2018
EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 23 Oct 2018
COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression
Biopharmaceuticals Neurology 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 - 24 Sep 2018
Tocagen Appoints Mohamed Ladha as Vice President to Establish Commercial Organization
Biopharmaceuticals Oncology Personnel
 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 - 23 Aug 2018
Tocagen's Toca 5 Pivotal Phase 3 Clinical Trial in Patients with Recurrent Brain Cancer Continues Without Modification at Planned First Interim Analysis
Biopharmaceuticals Neurology Oncology
 HSMN NewsFeed - 21 Aug 2018
Audentes Announces Regenerative Medicine Advanced Therapy (RMAT) Designation Granted by the FDA to AT132 for the Treatment of X-Linked Myotubular Myopathy
Biopharmaceuticals Regenerative Medicine FDA
 HSMN NewsFeed - 7 Aug 2018
Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVI(TM) in combination with MEKTOVI(R) and cetuximab for BRAFV600E-mutant Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Aug 2018
FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Jul 2018
MEI Pharma Promotes David M. Urso to Chief Operating Office
Biopharmaceuticals Oncology Personnel
 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 - 15 Jun 2018
MEI Pharma Presents Clinical Data on ME-401 at the European Hematology Association Congress
Biopharmaceuticals Oncology
 HSMN NewsFeed - 4 Jun 2018
Blueprint Medicines and CStone Pharmaceuticals Announce Exclusive Collaboration and License Agreement to Develop and Commercialize Avapritinib, BLU-554 and BLU-667 in Greater China
Biopharmaceuticals Oncology Licensing
 HSMN NewsFeed - 24 May 2018
IMBRUVICA(R) (ibrutinib) Plus GAZYVA(R) (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint
Biopharmaceuticals Oncology
 HSMN NewsFeed - 16 May 2018
Positive Phase 3 Trial of DUPIXENT(R) (dupilumab) in Adolescents with Inadequately Controlled Moderate-to-severe Atopic Dermatitis
Biopharmaceuticals Dermatology
 HSMN NewsFeed - 14 May 2018
Ansun BioPharma secures $85 million in Series A Financing
Biopharmaceuticals Venture Capital Personnel
 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 - 19 Apr 2018
Tocagen and ApolloBio Enter License Agreement to Develop and Commercialize Toca 511 & Toca FC in the Greater China Region
Biopharmaceuticals Oncology Licensing
 HSMN NewsFeed - 26 Mar 2018
Bayer Announces Completion of Rolling Submission of New Drug Application in the U.S. for Larotrectinib for the Treatment of TRK Fusion Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 Mar 2018
Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer
Biopharmaceuticals Oncology Urology FDA
 HSMN NewsFeed - 4 Jan 2018
Novartis drug Promacta(R) receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)
Biopharmaceuticals 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 - 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 - 18 Dec 2017
Novartis multiple sclerosis therapy fingolimod granted FDA Breakthrough Therapy designation for pediatric MS
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 16 Nov 2017
FDA Approves New Treatment to Prevent Bleeding in Certain Patients with Hemophilia A
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Oct 2017
FDA Grants Breakthrough Therapy Designation for BioMarin's Valoctocogene Roxaparvovec (formerly BMN 270), an Investigational Gene Therapy for Hemophilia A
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Sep 2017
Synthetic Biologics Announces Closing of $12 Million Convertible Preferred Stock Financing
Biopharmaceuticals Venture Capital
 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 - 29 Aug 2017
FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's DS-8201 for HER2-Positive Metastatic Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Jul 2017
Tocagen Receives European Medicines Agency Priority Medicines (PRIME) Designation for Toca 511 in High Grade Glioma
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 10 Jul 2017
Gamida Cell Inc. Names Ronit Simantov, M.D. as Chief Medical Officer
Regenerative Medicine Personnel
 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 - 5 Jun 2017
Gamida Cell Appoints Nobel Prize Laureate Professor Roger Kornberg and Immune Oncology Expert Dr. Michael Perry to its Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 5 Jun 2017
New Data Presented at ASCO 2017 Finds IMBRUVICA(R) (ibrutinib) May Offer a More Targeted Approach to Chronic Lymphocytic Leukemia (CLL) Treatment than Chemotherapy Agent Chlorambucil in Treatment-Naïve Patients
Biopharmaceuticals Oncology
 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 - 24 Apr 2017
Lilly Announces Phase 3 MONARCH 3 Breast Cancer Study of Abemaciclib Demonstrated Superior Progression-Free Survival at Interim Analysis
Biopharmaceuticals Oncology
 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 - 3 Apr 2017
MEI Pharma Announces Appointment of Brian Drazba as Chief Financial Officer
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 3 Apr 2017
Sucampo Acquires Vtesse Inc.
Biopharmaceuticals Mergers & Acquisitions
 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 - 20 Mar 2017
Lilly Announces Phase 3 MONARCH 2 Breast Cancer Study of Abemaciclib Met Primary Endpoint of Progression-Free Survival
Biopharmaceuticals Oncology
 HSMN NewsFeed - 24 Feb 2017
CHMP Issues Positive Opinion Recommending DARZALEX(R) (daratumumab) for Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 9 Feb 2017
Syndax Appoints Richard P. Shea as Chief Financial Officer
Biopharmaceuticals Oncology Personnel
 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 - 19 Jan 2017
U.S. FDA Approves IMBRUVICA(R) (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) - a Rare Type of Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 19 Dec 2016
AbbVie Submits New Drug Application to U.S. FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C
Biopharmaceuticals FDA
 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 - 16 Dec 2016
Grünenthal Receives Breakthrough Therapy Designation From U.S. FDA for Neridronic Acid for the Treatment of CRPS
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 - 22 Nov 2016
DARZALEX(R) (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Nov 2016
Gamida Cell Names Julian Adams, Ph.D. New Chairman of the Board
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 11 Nov 2016
Bristol-Myers Squibb’s Opdivo(R) (nivolumab) is the First Immuno-Oncology Treatment to Receive FDA Approval Based on Overall Survival in Head and Neck Cancer
Biopharmaceuticals Oncology 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 - 26 Sep 2016
AbbVie Announces Submission of a Supplemental New Drug Application for Ibrutinib (IMBRUVICA(R)) for Treatment of Marginal Zone Lymphoma
Biopharmaceuticals Oncology 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 - 10 Aug 2016
Lilly Provides Update on MONARCH 2 Phase 3 Trial of Abemaciclib
Biopharmaceuticals Oncology
 HSMN NewsFeed - 3 Aug 2016
Novartis CDK4/6 Inhibitor LEE011 (Ribociclib) Receives FDA Breakthrough Therapy Designation as First-Line Treatment for HR+/HER2- Advanced Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Jul 2016
Lilly and Boehringer Ingelheim Announce Clinical Trial Collaboration in Metastatic Breast Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 29 Jun 2016
AbbVie Announces Fourth Breakthrough Therapy Designation Granted by the U.S. Food and Drug Administration (FDA) for Ibrutinib (IMBRUVICA(R)) for Chronic Graft-Versus-Host-Disease (cGVHD), a Rare Condition with Limited Treatment Options
Biopharmaceuticals
 HSMN NewsFeed - 28 Jun 2016
FDA Grants Priority Review for Genentech’s OCREVUS(TM) (ocrelizumab) Biologics License Application
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 6 Jun 2016
Celator Pharmaceuticals(R) Presented Phase 3 Trial Results in Patients with High-Risk Acute Myeloid Leukemia Demonstrating VYXEOS(TM) (CPX-351) Significantly Improved Overall Survival
Biopharmaceuticals Oncology
 HSMN NewsFeed - 31 May 2016
Jazz Pharmaceuticals And Celator Pharmaceuticals Announce Agreement For Jazz Pharmaceuticals To Acquire Celator For $30.25 Per Share
Biopharmaceuticals Oncology Mergers & Acquisitions
 HSMN NewsFeed - 17 May 2016
Catalyst Pharmaceuticals Announces Reduction in Workforce as Part of Operating Expense Management Plan
Biopharmaceuticals
 HSMN NewsFeed - 9 May 2016
U.S. FDA Expands IMBRUVICA(R) (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and New Indication for Small Lymphocytic Lymphoma (SLL) Patients
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Apr 2016
Novartis Receives Three FDA Breakthrough Therapy Designations for IlaristTo Treat Rare Types of Periodic Fever Syndromes
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Apr 2016
New Analyses of the Phase 3 POISE Trial of Ocaliva(TM) (Obeticholic Acid) for the Treatment of PBC Presented at EASL
Biopharmaceuticals
 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 - 1 Apr 2016
Regeneron and Sanofi Announce Positive Dupilumab Topline Results from Two Phase 3 Trials in Inadequately Controlled Moderate-to-Severe Atopic Dermatitis Patients
Biopharmaceuticals Dermatology
 HSMN NewsFeed - 26 Feb 2016
Catalyst Pharmaceuticals Appoints Brian Elsbernd as Senior Vice President of Legal and Compliance
Biopharmaceuticals Personnel
 HSMN NewsFeed - 26 Feb 2016
AbbVie Receives EMA Orphan Drug Designation for Investigational Compound Venetoclax for the Treatment of Acute Myeloid Leukemia (AML)
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 17 Feb 2016
Catalyst Pharmaceuticals Receives "Refusal to File" Letter From the FDA on Its NDA for Firdapse
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Feb 2016
FDA Grants Breakthrough Therapy Designation for Genentech’s Investigational Medicine Ocrelizumab in Primary Progressive Multiple Sclerosis
Biopharmaceuticals Neurology 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 - 2 Feb 2016
Neurocrine Announces Initiation of Phase II Clinical Study of VMAT2 Inhibitor Valbenazine in Children and Adolescents with Tourette Syndrome
Biopharmaceuticals Neurology
 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 - 29 Jan 2016
Allergan's Rapastinel Receives FDA Breakthrough Therapy Designation for Adjunctive Treatment of Major Depressive Disorder (MDD)
Biopharmaceuticals Neurology FDA
 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 - 17 Dec 2015
Aimmune Therapeutics Appoints Jeffrey H. Knapp as Chief Operating Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 16 Dec 2015
BIND Therapeutics Appoints Jonathan Yingling, Ph.D., as Chief Scientific Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 18 Nov 2015
Merck KGaA, Darmstadt, Germany, and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Nov 2015
AbbVie Submits IMBRUVICA(R) (ibrutinib) Phase III Combination Data to U.S. FDA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Nov 2015
Seres Therapeutics Appoints Kurt Graves to Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 8 Oct 2015
Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib - a CDK 4 and 6 Inhibitor - in Advanced Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Sep 2015
U.S. FDA Grants Breakthrough Therapy Designation for Genentech’s Investigational Medicine ACE910 for People With Hemophilia A With Factor VIII Inhibitors
Biopharmaceuticals FDA
 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 Jul 2015
In a Pivotal Study, Genentech’s Investigational Immunotherapy Atezolizumab Shrank Tumors in People With a Specific Type of Bladder Cancer
Biopharmaceuticals Oncology Urology
 HSMN NewsFeed - 1 Jul 2015
Celldex Therapeutics Appoints Richard Wright as Chief Commercial Officer
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 27 Mar 2015
Atara Biotherapeutics, Inc. Appoints Eric Dobmeier, Chief Operating Officer of Seattle Genetics, Inc., to Its Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 5 Jan 2015
Catalyst Pharmaceuticals Appoints David D. Muth, Executive Vice President, Chief Commercial Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 5 Jan 2015
Aduro Biotech Closes $51.4 Million Series D Financing
Biopharmaceuticals Oncology Venture Capital
 HSMN NewsFeed - 18 Dec 2014
Scioderm, Inc. Closes $20 Million Series B Round of Financing
Biopharmaceuticals Dermatology Venture Capital
 HSMN NewsFeed - 16 Oct 2014
FDA Approves Boehringer Ingelheim's OFEV(R) (nintedanib) as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Sep 2014
Catalyst Pharmaceuticals Appoints David D. Muth as Executive Vice President, Corporate Development
Biopharmaceuticals Personnel
 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 - 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 - 21 May 2014
Provectus Biopharmaceuticals Inc. Appoints Jacob M. Plotsker to Strategic Advisory Board
Biopharmaceuticals Personnel
 HSMN NewsFeed - 29 Apr 2014
Novartis gains FDA approval for Zykadia(TM), first therapy for patients with ALK+ NSCLC previously treated with the ALK inhibitor crizotinib
Biopharmaceuticals Oncology
 HSMN NewsFeed - 28 Mar 2014
Catalyst Pharmaceutical Partners Expands Executive Leadership Team to Support the Commercialization of Firdapse(TM)
Biopharmaceuticals Neurology Personnel
 HSMN NewsFeed - 5 Mar 2014
Genmab Announces Phase III Study of Daratumumab in Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 13 Jan 2014
Merck Initiates Rolling Submission of U.S. Biologics License Application for MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Patients with Advanced Melanoma
Biopharmaceuticals Oncology 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 - 1 Nov 2013
FDA Approves Gazyva (Obinutuzumab) for People With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
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 - 24 Apr 2013
Merck Announces Breakthrough Therapy Designation for Lambrolizumab an Investigational Antibody Therapy for Advanced Melanoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 10 Apr 2013
Pfizer’s Palbociclib (PD-0332991) Receives Food And Drug Administration Breakthrough Therapy Designation For Potential Treatment Of Patients With Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Apr 2013
Ibrutinib Receives Third Oncology Breakthrough Therapy Designation from U.S. Food and Drug Administration
Biopharmaceuticals Oncology FDA
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