Healthcare Sales & Marketing Network News: FDA

Healthcare News Roundup: FDA

HSMN NewsFeed - 24 Sep 2020
Leap Therapeutics Announces FDA Fast Track Designation Granted to DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer
Biopharmaceuticals Oncology 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

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