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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 23 Aug 2017
Stryker provides an update regarding Sage warning letter and revised financial guidance
Biopharmaceuticals 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 - 22 Aug 2017
Jupiter Orphan Therapeutics Receives Orphan Drug Designation for its Trans-Resveratrol Product JOTROL for Treatment of Friedreich's Ataxia
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 21 Aug 2017
BIOTRONIK US Launches Smallest MR Conditional Quadripolar Cardiac Resynchronization Therapy Pacemaker
Devices Cardiology FDA Product Launch
 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 - 21 Aug 2017
Cardiome Provides U.S. Regulatory Update For BRINAVESS
Biopharmaceuticals Cardiology FDA
 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 - 8 Aug 2017
First FDA-Approved Treatment For ALS In 22 Years Now Available In U.S.
Biopharmaceuticals Neurology Product Launch
 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
Amgen and Allergan Submit Biosimilar Biologics License Application for ABP 980 to US Food and Drug Administration
Biopharmaceuticals Generics Oncology FDA
 HSMN NewsFeed - 31 Jul 2017
Accuray Receives 510(k) Clearance for iDMS(TM) Data Management System Upgrade for the TomoTherapy(R) System
Devices Oncology Neurosurgery 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
CSL Behring Receives Orphan-Drug Exclusivity for HAEGARDA(R) (C1 Esterase Inhibitor Subcutaneous [Human])
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jul 2017
Teligent, Inc. Announces FDA Approval Of Erythromycin Topical Gel USP, 2%
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 20 Jul 2017
Churchill Pharmaceuticals Announces NDA Filing Acceptance for YONSA(TM) by the U.S. FDA
Biopharmaceuticals Oncology 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 - 17 Jul 2017
Amgen And UCB Provide Update On Regulatory Status Of EVENITY(TM) (romosozumab) In The US
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Jul 2017
Lannett Receives Approval For Cyproheptadine Hydrochloride Syrup, 2 mg/5 mL
Biopharmaceuticals Generics 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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