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Healthcare News Roundup: FDA

 HSMN NewsFeed - 3 Apr 2020
BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in U.S.
Diagnostics FDA
 HSMN NewsFeed - 31 Mar 2020
enlightenVue's Single-Use Micro Endoscope Receives FDA 510(k) Clearance
Devices Surgery FDA
 HSMN NewsFeed - 30 Mar 2020
Lilly's Taltz(R) (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 27 Mar 2020
Cipla Receives Final Approval for Generic Version of AstraZeneca Pharmaceutical's Nexium(R) (Esomeprazole for Oral Suspension 10mg, 20mg and 40mg)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 27 Mar 2020
EchoNous, Inc. Announces FDA Approval for Its New KOSMOS Platform
Devices FDA
 HSMN NewsFeed - 26 Mar 2020
FDA Grants VERO Biotech Expanded Access Emergency Use for the Treatment of Patients with COVID-19, with the GENOSYL(R) DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 24 Mar 2020
BIOLASE Announces Regulatory Clearance of Laser Bacterial Reduction Therapy Indication for Epic Hygiene Laser
Devices Dental FDA
 HSMN NewsFeed - 23 Mar 2020
Biohaven to Advance Vazegepant into Phase 3 for the Acute Treatment of Migraine Following Successful End of Phase 2 Meeting with FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Mar 2020
Accelerated Road to Market Approval for CERAMENT(R) G in the US - BONESUPPORT(TM) Submits De Novo Application
Devices Orthopaedic Drug Delivery 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 - 18 Mar 2020
Biohaven's Verdiperstat Receives Fast Track Designation For The Treatment Of Multiple System Atrophy
Biopharmaceuticals 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 - 12 Mar 2020
Agenus Receives Fast Track Designation for Balstilimab & Zalifrelimab in Advanced Cervical Cancer
Biopharmaceuticals Oncology 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 - 24 Feb 2020
Lipocine Announces Regulatory Path Forward for TLANDO(TM) Resubmission
Biopharmaceuticals 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
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