Healthcare Sales & Marketing Network: FDA : Medical Device and Pharmaceutical News

Healthcare News Roundup: FDA

HSMN NewsFeed - 20 Mar 2020
Biostage Announces IND Approval from FDA for its Lead Product Candidate Cellspan(TM) Esophageal Implant
Devices Regenerative Medicine FDA

HSMN NewsFeed - 17 Mar 2020
Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization
Diagnostics Product Launch

HSMN NewsFeed - 16 Mar 2020
Lilly Receives FDA Breakthrough Therapy Designation for Baricitinib for the Treatment of Alopecia Areata
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Mar 2020
Soliton Receives FDA Clearance of Special 510(k)
Devices Dermatology FDA

HSMN NewsFeed - 9 Mar 2020
U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Bevacizumab for Review
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 5 Mar 2020
Magnolia Medical Receives FDA 510(k) Clearance for Expanded Steripath Gen2 Product Family
Devices FDA

HSMN NewsFeed - 3 Mar 2020
FDA Clears Next Generation HydroPICC from Access Vascular
Devices 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 - 2 Mar 2020
ANI Pharmaceuticals Announces FDA Approval of Memantine Hydrochloride Extended-Release Capsules
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 2 Mar 2020
FX Solutions, SAS. [FX Shoulder, Inc.] Receives FDA 510k Clearances for Glenoid Baseplate With a Central Screw and 32mm Glenosphere and Humeral Cups
Devices Orthopaedic FDA

HSMN NewsFeed - 26 Feb 2020
Evofem Biosciences Appoints Former FDA Division Director Lisa Rarick, M.D., to its Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 25 Feb 2020
EmCyte Announces FDA 510(k) Clearance for its PurePRP(R) Supraphysiologic Concentrating System
Devices FDA

HSMN NewsFeed - 21 Feb 2020
Cerus Endovascular Successfully Completes Series B Financing and Receives U.S. FDA Approval for its First Microcatheter
Devices Interventional Neurology Venture Capital 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 - 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
Soliton Files Special 510(k) with FDA for its Generation II RAP Device
Devices Dermatology FDA

HSMN NewsFeed - 11 Feb 2020
FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer(R) Inside-Out(R) Access Catheter System
Devices 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 - 31 Jan 2020
Olympus Announces FDA Clearance of the TJF-Q190V Duodenoscope
Devices Gastroenterology FDA

HSMN NewsFeed - 29 Jan 2020
Monoferric(R) (Ferric Derisomaltose) Injection Is Approved by the US FDA for the Treatment of Iron Deficiency Anemia
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Jan 2020
Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
Biopharmaceuticals Oncology FDA

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