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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 - 11 Feb 2016
Guerbet receives FDA 510k clearance for the OptiOne(TM) Single-Head Contrast Delivery System
Devices Radiology FDA
 HSMN NewsFeed - 11 Feb 2016
Wenzel Spine Announces FDA Clearance
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 11 Feb 2016
Lannett Receives FDA Approval For Temozolomide Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 Feb 2016
Amarantus Receives Orphan Drug Designation From the US FDA for Eltoprazine in the Treatment of Parkinson's Disease Levodopa-Induced Dyskinesia
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 10 Feb 2016
TransEnterix Finalizes FDA Submission Process Related to SurgiBot System 510(k) Application
Devices Surgery FDA
 HSMN NewsFeed - 10 Feb 2016
BD Receives FDA 510(k) Clearance for Diagnostic Device for HIV/AIDS
Devices Diagnostics HIV/AIDS FDA
 HSMN NewsFeed - 9 Feb 2016
LifeWatch(TM) Receives FDA Clearance for Its Continuous Vital Signs Monitoring Service
Devices Monitoring FDA
 HSMN NewsFeed - 8 Feb 2016
Angel Medical Systems Announces FDA Advisory Committee Meeting for Review of the AngelMed Guardian(R) System
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 8 Feb 2016
Sangamo BioSciences Announces FDA Clearance Of Investigational New Drug Application For ZFN-Mediated Genome Editing Treatment Of MPS I
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Feb 2016
Amarantus Requests Rare Pediatric Disease Designation from US FDA for MANF in the Treatment of Retinitis Pigmentosa
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 2 Feb 2016
Hansen Medical(R) Announces FDA Clearance of the Magellan(TM) Robotic Catheter eKit
Devices Interventional FDA
 HSMN NewsFeed - 2 Feb 2016
Impax Receives Tentative FDA Approval for Generic Version of Vytorin(R) (ezetimibe and simvastatin) Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg
Biopharmaceuticals Generics Cardiology FDA
 HSMN NewsFeed - 1 Feb 2016
Proteostasis Therapeutics Receives FDA Fast Track Designation for PTI-428 in Patients With Cystic Fibrosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Feb 2016
Dr. Reddy’s Laboratories Receives USFDA Tentative Approval for Zenavod(TM) (doxycycline) Capsules, 40 mg for the Treatment of Rosacea in Adults
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 29 Jan 2016
FDA Approves Eisai's Halaven(R) (eribulin mesylate) Injection for the Treatment of Patients with Advanced Liposarcoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Jan 2016
Merck Receives FDA Approval of ZEPATIER(TM) (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review
Biopharmaceuticals FDA Product Launch
 HSMN NewsFeed - 29 Jan 2016
Allergan's Rapastinel Receives FDA Breakthrough Therapy Designation for Adjunctive Treatment of Major Depressive Disorder (MDD)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 28 Jan 2016
Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT(TM) (Amphetamine Extended-Release Orally Disintegrating Tablet) for the Treatment of ADHD in Patients 6 Years and Older
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 28 Jan 2016
Venetoclax Receives 3rd Breakthrough Therapy Designation from the FDA for the Combination Treatment of Patients with Untreated Acute Myeloid Leukemia not Eligible for Standard Induction Chemotherapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 25 Jan 2016
Athenex Announces US FDA Allowance of the Investigation New Drug Application of Oradoxel, the Proprietary Oral Form of Docetaxel
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 25 Jan 2016
Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 23 Jan 2016
Cellceutix Releases Data Used in Receiving FDA Orphan Drug Designation of Kevetrin for Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Jan 2016
U.S. FDA Approves BOTOX(R) (onabotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jan 2016
Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for DALVANCE(R) (dalbavancin)
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Jan 2016
AbbVie's Venetoclax Receives Breakthrough Therapy Designation from FDA in Combination with Rituximab for the Treatment of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 19 Jan 2016
Medical Device Firm Advanced Cooling Therapy Receives 510(k) Clearance from FDA for Second Esophageal Cooling Device to Cool and Warm Patients
Devices FDA
 HSMN NewsFeed - 19 Jan 2016
Unique Biomaterial for Hernia Repair Receives FDA 510K Clearance
Devices Surgery FDA
 HSMN NewsFeed - 18 Jan 2016
LifeWatch Receives FDA Clearance for its Mobile Cardiac Telemetry 1-Lead Patch
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 16 Jan 2016
Novartis receives two new FDA approvals for Cosentyx(R) (secukinumab) to treat patients with ankylosing spondylitis and psoriatic arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Jan 2016
Edwards Receives FDA Approval For Expanded Indication Study Of SAPIEN 3 Valve
Devices Cardiology FDA
 HSMN NewsFeed - 13 Jan 2016
FDA Clears Siemens' New High-volume Coagulation Analyzer
Diagnostics Devices FDA
 HSMN NewsFeed - 12 Jan 2016
OptMed Receives FDA Marketing Clearance For Its Topical Surgical Skin Adhesive, BondEase(R)
Devices Surgery FDA
 HSMN NewsFeed - 11 Jan 2016
FDA Approves Animas(R) Vibe(R) Insulin Pump and Continuous Glucose Monitoring System For Use in Children
Devices Endocrinology Monitoring FDA
 HSMN NewsFeed - 8 Jan 2016
AcelRx Completes Protocol Review with FDA and Plans to Initiate Phase 3 Open-Label Study (IAP312) for Zalviso(TM) in 1Q 2016
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Jan 2016
Intellijoint Surgical Receives FDA Clearance for the Next Generation of intellijoint HIP(TM) -- A Miniature Surgical Smart Tool for Cup Position, Leg Length, and Offset in Hip Replacement Surgery
Devices Orthopaedic FDA
 HSMN NewsFeed - 6 Jan 2016
MST Receives FDA Clearance for "Follow Me(TM)" Image-Guided Software for Minimally Invasive Robotic Surgery
Devices Surgery FDA
 HSMN NewsFeed - 5 Jan 2016
Ionis Pharmaceuticals Receives Orphan Drug Designation from the US FDA for IONIS-HTT Rx for the Treatment of Patients with Huntington's Disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 4 Jan 2016
United-Guardian Receives FDA Approval to Market New Single-Dose Form of Renacidin(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Dec 2015
Amarantus Requests Rare Pediatric Disease and Orphan Drug Designations from US FDA for Engineered Skin Substitute in the Treatment of Giant Congenital Melanocytic Nevi
Devices Regenerative Medicine Dermatology FDA
 HSMN NewsFeed - 24 Dec 2015
Eagle Pharmaceuticals Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Dec 2015
LabStyle Innovations Receives U.S. FDA Marketing Clearance for the Dario Blood Glucose Monitoring System
Devices Monitoring Endocrinology FDA
 HSMN NewsFeed - 21 Dec 2015
Roche receives FDA approval for HIV-1 viral load test on the cobas(R) 6800/8800 Systems
Diagnostics HIV/AIDS FDA
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