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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

Healthcare News Roundup: FDA

 HSMN NewsFeed - 22 Sep 2020
NanoVibronix UroShield(R) Receives U.S. Food and Drug Administration Authorization for Entry into the U.S.
Devices FDA
 HSMN NewsFeed - 21 Sep 2020
BD Announces FDA Classifications for August 4th Recalls of BD Alaris(TM) System Hardware for Keypads, Incorrect Module Types and/or Sizes, and Channel Error
Devices Product Recall
 HSMN NewsFeed - 15 Sep 2020
ControlRad(R) Announces FDA Clearance and Closing of Series C Financing
Devices Radiology Venture Capital FDA
 HSMN NewsFeed - 8 Sep 2020
FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer
Diagnostics Oncology FDA
 HSMN NewsFeed - 7 Sep 2020
Ascentage Pharma's Bcl-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 3 Sep 2020
Fujifilm Sonosite Receives FDA COVID-19 510(k) Clearance for Comprehensive Point-of-Care Ultrasound Portfolio
Devices FDA
 HSMN NewsFeed - 27 Aug 2020
Healeon Announces FDA 510(k) Clearance for Duet Office-Based Blood Separation and Concentration System
Devices FDA
 HSMN NewsFeed - 27 Aug 2020
B. Braun Receives FDA Clearance for SpaceStation MRI: Allows Space(R) Infusion Pumps to Continuously Deliver Medications Within the MRI Suite
Devices Radiology FDA
 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 - 20 Aug 2020
BioMarin Submits New Drug Application to U.S. Food and Drug Administration for Vosoritide to Treat Children with Achondroplasia
Biopharmaceuticals 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 - 11 Aug 2020
MagVenture receives FDA clearance for OCD
Devices Neurology FDA
 HSMN NewsFeed - 11 Aug 2020
Deep Blue Medical Advances Announces FDA Clearance and U.S. Clinical Launch of the T-Line Hernia Mesh
Devices Surgery FDA Product Launch
 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 - 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 - 4 Aug 2020
ANA Therapeutics Announces U.S. FDA Clearance Of IND Application To Initiate Clinical Trial Of Niclosamide In COVID-19 Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Aug 2020
Stryker's Neuroform Atlas(R) Stent System granted an expanded indication, providing a new option for patients with aneurysms in the back of the brain
Devices Interventional Neurology 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 - 3 Aug 2020
Lannett Announces Launch Of FDA Approved Levothyroxine Tablets
Biopharmaceuticals Endocrinology Product Launch
 HSMN NewsFeed - 29 Jul 2020
Jay Pharma to File IND Applications to FDA for a clinical study of proprietary formulations in Radiodermatitis and a combination Therapy in Glioblastoma
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Jul 2020
Truvian Sciences Receives FDA Emergency Use Authorization for Easy Check COVID-19 IgM/IgG(TM) Test
Diagnostics FDA Product Launch
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