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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 - 22 Sep 2016
Sanaria(R) PfSPZ Vaccine Against Malaria Receives FDA Fast Track Designation
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Sep 2016
U.S. FDA Approves INVOKAMET(R) XR (Canagliflozin / Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 20 Sep 2016
KVK Tech Announces FDA-Approval of Lomaira(TM) (phentermine hydrochloride USP) 8 mg tablets, CIV, A Low-Cost, Low-Dose Phentermine That Can Be Used Up To Three Times Daily for Weight Reduction
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Sep 2016
GI View Ltd. Receives FDA 510(k) Clearance for the New Aer-O-Scope(R) Disposable Colonoscope System with Working Channels for Therapeutic Intervention During Colorectal Cancer Screening
Devices Oncology FDA
 HSMN NewsFeed - 20 Sep 2016
Lannett Announces Approval For Buprenorphine And Naloxone Sublingual Tablets, 2 mg/0.5 mg And 8 mg/2 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 19 Sep 2016
FDA-Cleared Bed Linens Engineered to Reduce Development of Pressure Ulcers
Devices Product Launch
 HSMN NewsFeed - 19 Sep 2016
Medeon Biodesign Receives FDA 510(k) Clearance for Abclose(TM) - Laparoscopic Port Site Closure Device
Devices Surgery FDA
 HSMN NewsFeed - 15 Sep 2016
Varian Medical Systems Receives FDA 510(k) Clearance for Nexus DR Digital X-Ray Imaging System
Devices Radiology Oncology FDA
 HSMN NewsFeed - 13 Sep 2016
Aptinyx Receives FDA Fast Track Designation for Development of NYX-2925 as Treatment for Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 13 Sep 2016
vBloc Institute Demonstrates Positive Clinical Success in Patients Struggling with Weight Loss as Compared to Pivotal FDA Trial with EnteroMedics vBloc(R) Therapy in Combination with vBloc(R) Achieve Program
Devices Neurology
 HSMN NewsFeed - 12 Sep 2016
Obalon Announces FDA Approval of Obalon Balloon System
Devices Gastroenterology FDA
 HSMN NewsFeed - 9 Sep 2016
BioVie's Lead Compound BIV201 Receives FDA Orphan-Drug Designation for the Treatment of Ascites
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Sep 2016
Monteris Medical Receives IDE Approval From FDA To Evaluate NeuroBlate(R) In Patients Newly Diagnosed With Glioblastoma Multiforme
Devices Oncology Neurosurgery FDA
 HSMN NewsFeed - 7 Sep 2016
FDA Grants Special Designation to TAXIS Pharmaceuticals Experimental Antibiotic
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Sep 2016
FDA allows Phrixus’s IND for Carmeseal-MD(TM) (P-188 NF) in Duchenne muscular dystrophy (DMD)
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Sep 2016
BD Submits Pre-Market Approval Application to FDA for BD Onclarity(TM) HPV Test
Diagnostics FDA
 HSMN NewsFeed - 5 Sep 2016
Dynavax Provides Regulatory Update on HEPLISAV-B
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Sep 2016
FDA Approves New AGGRASTAT(R) Product Format
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 1 Sep 2016
Kamada and Kedrion Seek FDA Approval of Human Rabies Immunoglobulin as a Post-Exposure Treatment
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Aug 2016
Fortimedix Surgical Announces 510(k) Clearance for Innovative Single-port Surgical Platform
Devices Surgery FDA
 HSMN NewsFeed - 29 Aug 2016
Roche receives FDA Emergency Use Authorization for Zika PCR Test
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Aug 2016
Mallinckrodt Receives FDA Fast-Track Designation for Synacthen(R) Depot IND Application
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Aug 2016
Amgen Provides Update On Status Of Parsabiv(TM) (Etelcalcetide) New Drug Application (NDA) Submitted To The U.S. Food And Drug Administration (FDA)
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Aug 2016
ImPACT(R) is the First Concussion-Specific Medical Device to Receive FDA Clearance
Devices Neurology FDA
 HSMN NewsFeed - 23 Aug 2016
Perrigo Announces Tentative FDA Approval For Generic Version Of Suprep(R) Oral Solution And Confirms Patent Challenge For Generic Version Of Mirvaso(R) Gel
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 19 Aug 2016
Alere Receives FDA Clearance for Alere(TM) i RSV Rapid Molecular Test
Diagnostics FDA
 HSMN NewsFeed - 18 Aug 2016
FDA Grants Soligenix Orphan Drug Designation for Dusquetide for Treatment of Macrophage Activation Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Aug 2016
Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa(TM) (andexanet alfa)
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Aug 2016
Trillium Therapeutics Receives FDA Clearance to Proceed With TTI-621 in Clinical Trial Targeting Solid Tumors and Mycosis Fungoides
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Aug 2016
Bovie Medical Receives FDA 510(k) Clearance for Its PlazXact(TM) Ablator
Devices Orthopaedic Surgery FDA
 HSMN NewsFeed - 15 Aug 2016
Conventus Orthopaedics delivers additional Cage Technology fracture solutions with new Distal Ulna and Proximal Ulna product indications for innovative 3-dimensional fixation
Devices Orthopaedic FDA
 HSMN NewsFeed - 10 Aug 2016
Heron Therapeutics Announces U.S. FDA Approval of SUSTOL(R) (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Aug 2016
Centric Medical(TM) Announces FDA Clearance of Hammertoe Correction System
Devices Orthopaedic FDA
 HSMN NewsFeed - 9 Aug 2016
Boston Scientific Announces U.S. FDA Approval Of EMBLEM(TM) MRI S-ICD System
Devices Cardiology FDA
 HSMN NewsFeed - 4 Aug 2016
DNAtrix Awarded FDA Orphan Products Development Grant for DNX-2401
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 3 Aug 2016
FDA Approves FLONASE(R) Sensimist(TM) Allergy Relief
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Aug 2016
Novartis CDK4/6 Inhibitor LEE011 (Ribociclib) Receives FDA Breakthrough Therapy Designation as First-Line Treatment for HR+/HER2- Advanced Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Aug 2016
GORE(R) TIGRIS(R) Vascular Stent Gains FDA Approval for Treatment of Peripheral Artery Disease
Devices Interventional FDA
 HSMN NewsFeed - 1 Aug 2016
Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport(R) (Abobotulinumtoxin A) for the Treatment of Lower Limb Spasticity in Pediatric Patients Aged Two and Older
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Aug 2016
Shire Announces FDA Approval of adynovate with BAXJECT III Reconstitution System
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Aug 2016
Ipsen Announces FDA Approval of Dysport(R) (abobotulinumtoxinA) for Injection for the Treatment of Lower Limb Spasticity in Children Aged Two and Older
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Aug 2016
Roche receives CLIA waiver for cobas(R) Influenza A/B & RSV test for the cobas(R) Liat(R)
Diagnostics FDA
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