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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 - 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
 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 - 27 Jul 2020
Stratus(TM) Medical announces FDA 510k clearance for the Vesta(TM) RF Cannula to expand product portfolio and the first Vesta patient treatments in the United States
Devices FDA
 HSMN NewsFeed - 27 Jul 2020
CARISMA Therapeutics Announces FDA Clearance of IND Application for First-Ever Engineered Macrophage Immunotherapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Jul 2020
Abbott Receives FDA Approval for iOS-Compatible App Allowing People Living With Chronic Pain and Movement Disorders to Personalize Therapy Via Their Mobile Device
Devices Neurology FDA
 HSMN NewsFeed - 23 Jul 2020
FDA Clears First Blood Test for Identifying a Novel Allergic Sensitization to Red Meat
Diagnostics FDA
 HSMN NewsFeed - 23 Jul 2020
Beckman Coulter's Automated Blood Banking Analyzer Receives 510(k) FDA Clearance
Diagnostics FDA
 HSMN NewsFeed - 22 Jul 2020
Cerapedics Announces FDA approval of an IDE supplement
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 22 Jul 2020
Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 22 Jul 2020
BD receives FDA Approval for HPV Test with Extended Genotyping Capabilities
Diagnostics Oncology FDA
 HSMN NewsFeed - 22 Jul 2020
Luminex Files for Emergency Use Authorization for Expanded NxTAG Respiratory Panel Test Including SARS-CoV-2
Diagnostics FDA
 HSMN NewsFeed - 21 Jul 2020
LifeSignals Wireless Medical Biosensor LP1250 receives FDA clearance
Devices Monitoring FDA
 HSMN NewsFeed - 21 Jul 2020
Channel Medsystems(R) Receives FDA Approval of its Latest Cerene(R) Cryotherapy Device for the Treatment of Heavy Menstrual Bleeding in the Office Setting
Devices FDA
 HSMN NewsFeed - 20 Jul 2020
FDA Clears Abivertinib for Phase 2 Safety and Efficacy Study in Hospitalized Patients with Moderate To Severe Covid-19
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Jul 2020
FX Solutions, SAS. [FX Shoulder, Inc.] Receives FDA 510k Clearances for TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres
Devices Orthopaedic FDA
 HSMN NewsFeed - 20 Jul 2020
Luminex Receives FDA Emergency Use Authorization for COVID-19 Antibody Test
Diagnostics FDA
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