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

Healthcare News Roundup: FDA

HSMN NewsFeed - 23 Aug 2017
Epygenix Therapeutics Receives US FDA Orphan Drug Designation for EPX-300 for the Treatment of Patients With Dravet Syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 21 Aug 2017
Perrigo Announces Final FDA Approval and Settlement for the Store Brand OTC Equivalent of Nexium(R) 24HR Capsules
Biopharmaceuticals Generics FDA Litigation

HSMN NewsFeed - 18 Aug 2017
Prollenium Medical Technologies Inc. announces U.S. FDA approval for its cross-linked hyaluronic acid dermal filler
Devices Dermatology FDA

HSMN NewsFeed - 16 Aug 2017
Perrigo Announces FDA Final Approval for its AB Rated Generic Version of Mycolog(R) II Cream
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 15 Aug 2017
Camber Spine Technologies Announces FDA Clearance And National Launch Of SPIRA(TM) Open Matrix ALIF
Devices Orthopaedic Neurosurgery FDA Product Launch

HSMN NewsFeed - 11 Aug 2017
Renovis(R) Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 9 Aug 2017
Ocugen Receives FDA Orphan Drug Designation for OCU300 (brimonidine tartrate) for the Treatment of Ocular Graft Versus Host Disease
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 8 Aug 2017
AUM Cardiovascular Receives FDA Approval For Revolutionary Diagnostic Heart Device
Devices Cardiology FDA

HSMN NewsFeed - 7 Aug 2017
FDA Approves Medicines360's sNDA for LILETTA(R) (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Four Years
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 31 Jul 2017
Immunalysis Receives FDA Clearance for SEFRIA(TM) Fentanyl Urine Drug Screening Test
Diagnostics FDA

HSMN NewsFeed - 28 Jul 2017
Haemonetics Announces FDA Clearance of New Plasmapheresis System Branded NexSys PCS(TM)
Devices FDA

HSMN NewsFeed - 28 Jul 2017
Bracco Diagnostics Inc. Receives U.S. FDA Approval for VARIBAR(R) NECTAR (barium sulfate) Oral Suspension
Diagnostics Radiology Gastroenterology FDA

HSMN NewsFeed - 28 Jul 2017
FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For Repatha(R) (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 27 Jul 2017
U.S. FDA Grants Priority Review for an Epinephrine Auto-Injector in Development by Kaléo Specifically for Infants and Small Children
Biopharmaceuticals Devices Drug Delivery FDA

HSMN NewsFeed - 27 Jul 2017
Eiger Announces FDA Fast Track Designation Granted for Pegylated Interferon Lambda in Hepatitis Delta Virus Infection
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Jul 2017
Luminex Corporation Receives FDA Clearance for ARIES C. difficile Assay
Diagnostics FDA

HSMN NewsFeed - 21 Jul 2017
Teligent, Inc. Announces FDA Approval Of Erythromycin Topical Gel USP, 2%
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 19 Jul 2017
BD Receives FDA 510(k) Clearance for New Immunological Diagnostic System
Devices Diagnostics FDA

HSMN NewsFeed - 18 Jul 2017
Capricor Receives Rare Pediatric Disease Designation from FDA for CAP-1002 for Patients with Duchenne Muscular Dystrophy
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Jul 2017
U.S. FDA Designates Mallinckrodt's StrataGraft(R) as Regenerative Medicine Advanced Therapy
Regenerative Medicine FDA

HSMN NewsFeed - 12 Jul 2017
Saebo Announces FDA Clearance of SaeboVR - World's First Virtual ADL Rehabilitation System
Devices Neurology FDA

HSMN NewsFeed - 11 Jul 2017
Stryker's MultiGen(R) 2 Radiofrequency Generator Receives FDA 510(k) Clearance
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 11 Jul 2017
The FDA has Accepted an Orphan Designation Request for use of Truveta Administered Intranasally Submitted by Axium Pharmaceuticals Inc.
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 10 Jul 2017
FDA Grants Priority Review for Lilly's Abemaciclib for the Treatment of Advanced Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 6 Jul 2017
IsoRay Receives FDA Response to 510(k) Application for GammaTile(TM)
Devices Oncology FDA

HSMN NewsFeed - 6 Jul 2017
Biohaven's BHV-5000 Receives Orphan Drug Designation from the FDA in Rett Syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 5 Jul 2017
Edwards' INSPIRIS RESILIA Valve Receives FDA Approval
Devices Cardiology FDA

HSMN NewsFeed - 4 Jul 2017
FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
Devices Oncology FDA

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