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Healthcare News Roundup: 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 - 4 Feb 2020
Abbott's In-Development Fully Implantable Heart Pump System Earns FDA's Breakthrough Device Designation
Devices Cardiology FDA
 HSMN NewsFeed - 3 Feb 2020
7D Surgical Expands Spine and Cranial Technology Offering
Devices Neurosurgery FDA Product Launch
 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
 HSMN NewsFeed - 28 Jan 2020
BioIntelliSense Announces FDA Clearance of the BioSticker(TM), the First Single-Use Medical Device Enabling 30 Days of Continuous Vital Signs Monitoring
Devices Monitoring FDA Product Launch
 HSMN NewsFeed - 28 Jan 2020
Beckman Coulter's Access PCT Procalcitonin Assay Receives U.S. FDA 510(k) Clearance
Devices Diagnostics FDA
 HSMN NewsFeed - 27 Jan 2020
Ninety Percent of Patients Can't Use Inhalers Correctly, Digital Inhaler CapMedic Receives FDA Clearance to Change That
Devices Drug Delivery FDA
 HSMN NewsFeed - 24 Jan 2020
Abbott Receives Expanded Indication From the U.S. FDA for Directional Deep Brain Stimulation System to Treat Parkinson's Disease
Devices Neurology FDA
 HSMN NewsFeed - 22 Jan 2020
Celularity Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Jan 2020
VivaLNK Announces World's First FDA Cleared Wearable ECG Sensor Platform
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 17 Jan 2020
DURECT Corporation Announces Outcome of FDA Advisory Committee Meeting for POSIMIR(R)
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 16 Jan 2020
ANI Pharmaceuticals Announces FDA Approval of Potassium Citrate Extended-Release Tablets USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 13 Jan 2020
Dova Granted Orphan Drug Designation for Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Jan 2020
Lannett Announces FDA Approval Of NDA For Branded Anesthetic Product, Cocaine Hydrochloride Nasal Solution 4%
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 9 Jan 2020
Presage Receives FDA Clearance of First IND Application for Trial to Evaluate Investigational Oncology Agents with CIVO(TM) Technology
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 9 Jan 2020
MicroVention Announces FDA Premarket Approval of a New Flow Diverter for the Treatment of Brain Aneurysms
Devices Interventional Neurology FDA
 HSMN NewsFeed - 8 Jan 2020
Aruvant Receives FDA Rare Pediatric Disease Designation for ARU-1801 for the Treatment of Sickle Cell Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Jan 2020
IceCure Receives FDA Clearance for Expanded Indications of Cryoablation Technology and Regulatory Approval of New MultiSense System; Plans to Increase U.S. Presence and Operations
Devices Oncology FDA
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