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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 Oct 2015
Iroko Pharmaceuticals Receives FDA Approval for VIVLODEX(TM) - First Low Dose SoluMatrix(R) Meloxicam for Osteoarthritis Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Oct 2015
Spectrum Pharmaceuticals Receives Complete Response Letter (CRL) from U.S. Food and Drug Administration (FDA) for EVOMELA(TM) (melphalan) for Injection
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Oct 2015
Merrimack Announces U.S. FDA Approval of ONIVYDE(TM) (irinotecan liposome injection) for the Treatment of Patients with Metastatic Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Oct 2015
INSIGHTEC Submits Pre-Market Application (PMA) for FDA Approval of Exablate Neuro for Treatment of Essential Tremor
Devices Neurology Neurosurgery FDA
 HSMN NewsFeed - 19 Oct 2015
MedMira Receives FDA Approval for the Reveal(R) G4 Rapid HIV-1 Antibody Test
Diagnostics FDA
 HSMN NewsFeed - 14 Oct 2015
Eclipse(TM) Treatment Planning Software from Varian Now Offers Robust Optimization and Proton Therapy Dose Calculation Tools
Devices Oncology FDA Product Launch
 HSMN NewsFeed - 13 Oct 2015
Baxter Announces U.S. FDA Clearance for AMIA Automated Peritoneal Dialysis System with SHARESOURCE Connectivity Platform
Devices FDA
 HSMN NewsFeed - 13 Oct 2015
GTx Receives FDA Clearance to Initiate Clinical Trial in Stress Urinary Incontinence
Biopharmaceuticals Urology FDA
 HSMN NewsFeed - 12 Oct 2015
Endologix Announces FDA Approval of AFX(R)2 Bifurcated Endograft System
Devices Interventional FDA
 HSMN NewsFeed - 12 Oct 2015
NuVasive Receives First Ever FDA 510(k) Clearance of Cervical Corpectomy Cage
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 8 Oct 2015
Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib - a CDK 4 and 6 Inhibitor - in Advanced Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Oct 2015
FDA Approves INSIGHTEC's Next Generation Exablate Fibroid Treatment System and Removes Requirement for Patients to be Family Complete
Devices FDA
 HSMN NewsFeed - 7 Oct 2015
Luminex Corporation Receives FDA Clearance for ARIES(R) System and ARIES(R) HSV 1&2 Assay
Diagnostics FDA
 HSMN NewsFeed - 6 Oct 2015
Vertera Spine Announces FDA Clearance of the First Surface Porous PEEK Interbody Fusion Device
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 6 Oct 2015
FDA Clears CorPath(R) System for Robotic-assisted Radial Access PCI Procedures
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 5 Oct 2015
Otonomy Receives FDA Clearance of Investigational New Drug Application for Tinnitus Product Candidate, OTO-311
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Oct 2015
Boston Scientific Receives FDA Approval For SYNERGY(TM) Bioabsorbable Polymer Drug-Eluting Stent System
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 2 Oct 2015
Amicus Therapeutics Provides U.S. Regulatory Update for Migalastat Monotherapy
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Oct 2015
U.S. FDA Approves JUVEDERM(R) ULTRA XC for Use in Lips
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 1 Oct 2015
Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Sep 2015
Blueprint Medicines Receives FDA Orphan Drug Designation for Novel Drug Candidate for Treatment of Hepatocellular Carcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Sep 2015
Intact Vascular Announces Conditional FDA Approval for Tack Optimized Balloon Angioplasty II (TOBA II) Study and Enrollment of First Patients
Devices Interventional FDA
 HSMN NewsFeed - 29 Sep 2015
ArtVentive Medical Receives FDA Clearance for Larger Size EOS(TM) Device
Devices Interventional FDA
 HSMN NewsFeed - 25 Sep 2015
Merck and Pfizer Announce FDA Orphan Drug Designation for Investigational Immunotherapy Avelumab in Merkel Cell Carcinoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Sep 2015
Advanced Catheter Therapies Receives Second FDA 510(k) Clearance on Occlusion Perfusion Catheter
Devices Interventional FDA
 HSMN NewsFeed - 18 Sep 2015
Mylan Launches One of First Generic Lescol XL(R) Tablets
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 17 Sep 2015
Cook Medical Receives FDA Approval for the Zenith Alpha(TM) Thoracic Endovascular Graft
Devices Interventional FDA
 HSMN NewsFeed - 17 Sep 2015
Precision Spine(TM) Announces FDA Approval of the Reform(R) Modular and HA Coated Pedicle Screw Systems
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 17 Sep 2015
Impax Receives FDA Approval for Generic Version of Mestinon(R) Timespan(R) Tablets, 180 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 15 Sep 2015
FDA Approves Octapharma’s NUWIQ for the Treatment of Adults and Children with Hemophilia
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Sep 2015
Amgen Submits Application To FDA For New Delivery Option For Monthly Administration Of Repatha(TM) (Evolocumab)
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 11 Sep 2015
AbbVie's HUMIRA(R) (Adalimumab) Receives First and Only U.S. Food and Drug Administration Approval for Moderate to Severe Hidradenitis Suppurativa
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 4 Sep 2015
U.S. FDA Grants Breakthrough Therapy Designation for Genentech’s Investigational Medicine ACE910 for People With Hemophilia A With Factor VIII Inhibitors
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Sep 2015
Surefire Medical Receives FDA Clearance for Precision Direct-to-Tumor Embolization Device
Devices Drug Delivery Interventional Oncology FDA
 HSMN NewsFeed - 31 Aug 2015
FDA Grants Priority Review for Intercept's Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis
Biopharmaceuticals FDA
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