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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 - 5 Oct 2010
Accera, Inc. Appoints Dr. Thomas Werner President & CEO and Announces FDA Acceptance of IND Application for AC-1204 for Mild-to-Moderate Alzheimer's Disease
Biopharmaceuticals Neurology Personnel FDA
 HSMN NewsFeed - 4 Oct 2010
Orthovita Receives FDA Clearance for VITOMATRIX(TM) Bone Graft Substitute in Dental Applications
Devices Dental FDA
 HSMN NewsFeed - 4 Oct 2010
FDA Issues Complete Response Letter to Johnson & Johnson Pharmaceutical Research & Development Regarding New Drug Application for Tapentadol Extended Release
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Oct 2010
NovaBone Putty(R) MIS Delivery System Approved by FDA for Orthopedic Surgery
Devices Orthopaedic Surgery FDA
 HSMN NewsFeed - 4 Oct 2010
DFine Announces FDA 510(k) Clearance of New Radiofrequency Ablation System for Metastatic Spinal Lesions
Devices Oncology FDA
 HSMN NewsFeed - 4 Oct 2010
Celsion Receives Positive FDA Guidance for its New Drug Application for ThermoDox(R) to Treat Primary Liver Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Sep 2010
Wenzel Spine Announces FDA 510K Clearance
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 29 Sep 2010
Quidel Announces FDA Clearance of Its QuickVue(R) RSV 10 Immunoassay Diagnostic Test
Diagnostics FDA
 HSMN NewsFeed - 27 Sep 2010
Guided Therapeutics Files Premarket Approval Application for Non-Invasive Cervical Cancer Scanner with FDA
Devices Diagnostics Oncology FDA
 HSMN NewsFeed - 27 Sep 2010
Centocor Ortho Biotech Inc. Submits Application to FDA Seeking to Expand SIMPONI(R) Label in Treatment of Rheumatoid Arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Sep 2010
Hologic's Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System Receives Favorable Votes From FDA Advisory Panel
Devices Radiology Oncology FDA
 HSMN NewsFeed - 24 Sep 2010
ArthroCare Receives FDA Clearance for Parallax Contour Vertebral Augmentation Device
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 24 Sep 2010
Cook Medical Files Pre-Market Approval Application for FDA Approval of A Balloon Expandable Stent for Renal Artery Disease
Devices Interventional FDA
 HSMN NewsFeed - 22 Sep 2010
Roche Receives FDA Approval for Second-Generation Hepatitis B Viral Load Test
Diagnostics FDA
 HSMN NewsFeed - 22 Sep 2010
Biogen Idec Makes Statement About U.S. FDA Approval of Gilenya
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 22 Sep 2010
Novartis gains FDA approval for Gilenya, a novel first-line multiple sclerosis treatment shown to significantly reduce relapses and delay disability progression
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 21 Sep 2010
Athersys Receives Orphan Drug Designation for MultiStem in Graft vs. Host Disease
Regenerative Medicine FDA
 HSMN NewsFeed - 20 Sep 2010
Medtronic Receives FDA Approval of Integrity(R) Coronary Stent
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 15 Sep 2010
FDA Clears Medivance's Arctic Sun 5000 for Fastest, Easiest Therapeutic Temperature Management
Devices FDA
 HSMN NewsFeed - 14 Sep 2010
Cell Therapeutics to Appeal FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Sep 2010
Roche Receives FDA Clearance for U.S. Launch of cobas 8000 Modular Analyzer Series for High-Volume Laboratory Testing
Devices Diagnostics FDA
 HSMN NewsFeed - 10 Sep 2010
FDA Approves New Dosing for FASLODEX(R) (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 9 Sep 2010
Aesculap Implant Systems, LLC Receives FDA 510(k) Clearance for the S4(R) Cervical Occipital Plating System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 8 Sep 2010
Viking Systems Receives FDA 510(k) Clearance for Its Next Generation 3DHD Visualization System
Devices Surgery FDA
 HSMN NewsFeed - 7 Sep 2010
FDA Advisory Committee Recommends Approval of Forest Laboratories' Ceftaroline Fosamil for the Treatment of Community Acquired Bacterial Pneumonia and Complicated Skin and Skin Structure Infections
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Sep 2010
Watson's Generic Yasmin(R) Receives FDA Approval
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 7 Sep 2010
FDA Grants Market Clearance for Erchonia's Zerona Laser
Devices FDA
 HSMN NewsFeed - 7 Sep 2010
Teleflex Announces FDA 510(k) Market Clearance of Its ArrowEVOLUTION Pressure Injectable Peripherally Inserted Central Catheter with Chlorag+ard Technology
Devices FDA
 HSMN NewsFeed - 7 Sep 2010
K2M Receives 510(k) Clearance for its CHESAPEAKE Anterior-Lumbar Stabilization System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 1 Sep 2010
InfraReDx Receives FDA Clearance for LipiScan IVUS Coronary Imaging System
Devices Cardiology
 HSMN NewsFeed - 31 Aug 2010
Allergan, Inc. Receives FDA Approval for LUMIGAN(R) 0.01% as First-Line Therapy Indicated for the Reduction of Elevated Intraocular Pressure in Glaucoma Patients
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 31 Aug 2010
Quidel Announces FDA Clearance of Its RapidVue(R) hCG Pregnancy Lateral Flow Diagnostic Test
Diagnostics FDA
 HSMN NewsFeed - 27 Aug 2010
Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 27 Aug 2010
Genentech Provides Update on FDA Application for T-DM1
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 25 Aug 2010
Medyssey Spine Receives FDA 510(k) Clearance for Zenius(TM) Thoracolumbar Spinal System in Titanium Alloy (Ti6AL-4V ELI)
Devices FDA Orthopaedic Neurosurgery
 HSMN NewsFeed - 25 Aug 2010
Neuralstem Files FDA Application for First Chronic Spinal Cord Injury Stem Cell Trial
Regenerative Medicine
 HSMN NewsFeed - 25 Aug 2010
Actelion Pharmaceuticals Announces FDA Approval of Brand Name for Commercially Available VELETRI(R) (epoprostenol for injection) for Pulmonary Arterial Hypertension
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Aug 2010
Celsion Receives Fast Track Designation for ThermoDox(R) Development Program to Treat Primary Liver Cancer
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 23 Aug 2010
Radiometer's New ABL90 FLEX POC Analyzer Receives 510(k) Clearance
Devices FDA
 HSMN NewsFeed - 19 Aug 2010
Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for BENLYSTA(R) (belimumab) as a Potential Treatment for Systemic Lupus Erythematosus
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Aug 2010
Ipilimumab Receives FDA Priority Review Designation for Adult Patients with Previously Treated Advanced Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Aug 2010
ImmunoGen, Inc. Announces Orphan Drug Designation Granted to Lorvotuzumab Mertansine for Treatment of Small-Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Aug 2010
Aesculap Implant Systems, Inc. Receives FDA 510(k) Clearance for the A-Fix (SIBD) Spinal System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 18 Aug 2010
BSD Medical Receives FDA 510(k) Clearance to Market the MicroThermX Microwave Ablation System
Devices Oncology FDA
 HSMN NewsFeed - 16 Aug 2010
Microsulis Medical Limited Receives FDA 510(k) Clearance of Accu2i Percutaneous Microwave Tissue Ablation Device
Devices Oncology FDA
 HSMN NewsFeed - 13 Aug 2010
Watson Plans Q4 2010 ella(R) (ulipristal acetate) Emergency Contraceptive Launch
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Aug 2010
FDA Grants Approval of ella(R) for Emergency Contraception
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Aug 2010
FDA Grants Fenwal New 510(k) Clearance
Devices FDA
 HSMN NewsFeed - 12 Aug 2010
Meda: Ezogabine Receives Positive Vote From FDA Advisory Committee
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 10 Aug 2010
Onset Medical Receives US FDA Marketing Clearance for Additional Size Applications for the SoloPath Endovascular Access Catheter
Devices Interventional FDA
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