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Healthcare News Roundup: FDA

 HSMN NewsFeed - 29 Dec 2009
VIVUS Submits Qnexa(R) New Drug Application to the FDA for the Treatment of Obesity
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Dec 2009
FDA Accepts for Review Questcor's Filing of Its Supplemental New Drug Application for H.P. Acthar(R) Gel for Treatment of Infantile Spasms
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Dec 2009
Bovie Medical Corporation Announces FDA 510(k) Clearance to Market Resistick II Coated Electrodes
Devices Surgery FDA
 HSMN NewsFeed - 22 Dec 2009
AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Gram-Negative Bloodstream Pathogens
Diagnostics FDA
 HSMN NewsFeed - 22 Dec 2009
Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories' New Drug Application (NDA) for Efavirenz Tablets
Biopharmaceuticals HIV/AIDS
 HSMN NewsFeed - 22 Dec 2009
Shire Submits Biologics License Application (BLA) for REPLAGAL(R) With the U.S. Food and Drug Administration (FDA)
Biopharmaceuticals
 HSMN NewsFeed - 21 Dec 2009
Dilon Diagnostics Gamma-Guided Localization System Cleared by FDA
Devices Radiology Oncology FDA
 HSMN NewsFeed - 17 Dec 2009
FDA Approves SPIRIVA(R) HandiHaler(R) for the Reduction of COPD Exacerbations
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 17 Dec 2009
Sepracor Granted Patent Term Extension for LUNESTA(R) and Provides Update on LUNESTA Pediatric Studies
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Dec 2009
FDA Broadens Clearance for Agendia's MammaPrint(R)
Diagnostics Oncology FDA
 HSMN NewsFeed - 17 Dec 2009
Osteotech Submits 510(k) Application to FDA for Clearance of its Duratech(TM) BioRegeneration Matrix
Devices Neurosurgery
 HSMN NewsFeed - 17 Dec 2009
Cell Therapeutics Announces FDA's Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma, February 10, 2010
Biopharmaceuticals Oncology
 HSMN NewsFeed - 15 Dec 2009
EnzySurge Receives FDA Approval for SilverStream(TM) Innovative Wound Management Solution
Devices Wound Care FDA
 HSMN NewsFeed - 14 Dec 2009
Dilon Diagnostics Gamma-Guided Localization System Cleared by FDA
Devices Radiology Oncology FDA
 HSMN NewsFeed - 14 Dec 2009
FDA Approves Lilly's ZYPREXA(R) RELPREVV(TM) for Treatment of Schizophrenia in Adults
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Dec 2009
FDA Grants Emergency Use Authorization for DxNA's GeneSTAT(TM) Integrated PCR-based Influenza Detection System for H1N1 Virus
Diagnostics FDA
 HSMN NewsFeed - 10 Dec 2009
FDA clears Nexstim's Navigated Brain Stimulation for non-invasive cortical mapping prior to neurosurgery
Devices Neurosurgery FDA
 HSMN NewsFeed - 10 Dec 2009
AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Staphylococcal Bloodstream Pathogens
Diagnostics FDA
 HSMN NewsFeed - 8 Dec 2009
Stem Cell Based Treatment for Spinal Muscular Atrophy Receives Orphan Drug Designation
Regenerative Medicine FDA
 HSMN NewsFeed - 8 Dec 2009
BHR Pharma Files Investigational New Drug Application, Receives Orphan Drug Designation, for Traumatic Brain Injury Treatment
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 7 Dec 2009
r4 Vascular Receives FDA 510(k) Clearance to Market the First Power-Injectable Apheresis Catheter
Devices FDA
 HSMN NewsFeed - 7 Dec 2009
Octapharma USA Announces FDA Approval of wilate(R) - the First Replacement Therapy Developed Specifically for von Willebrand Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Dec 2009
FDA Grants First Approval for a Product Derived from Pichia pastoris
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Dec 2009
Somaxon Receives Complete Response Letter from the FDA for Silenor(R) NDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Dec 2009
FDA Approves Lilly's Zyprexa for Two Adolescent Indications
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Dec 2009
St. Jude Medical Receives FDA Approval for Industry-First Five-Column Neurostimulation Lead to Manage Chronic Pain
Devices Neurology FDA
 HSMN NewsFeed - 4 Dec 2009
US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Dec 2009
Cardium Files FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Topical Gel and ExcellagenFX(TM) Flowable Collagen Protein-Based Matrix for Diabetic, Pressure and Venous Ulcers and Other Dermal Wounds
Devices Wound Care FDA
 HSMN NewsFeed - 3 Dec 2009
Spectranetics Announces FDA Clearance of VisiSheath Dilator Sheath, New Lead Management Device
Devices Cardiology FDA
 HSMN NewsFeed - 3 Dec 2009
Nasal-Aire(R) II Petite Receives FDA 510(k) Clearance for Pediatric Use
Devices FDA
 HSMN NewsFeed - 3 Dec 2009
Amneal Receives FDA Approval for Nizatidine Oral Solution, the First Generic Oral Solution for Axid(R) in the Market
Biopharmaceuticals FDA Generics
 HSMN NewsFeed - 3 Dec 2009
New Neurostimulation Patient Programming Software Enables More Thorough and Efficient Capture of Complex Pain Patterns
Devices FDA
 HSMN NewsFeed - 2 Dec 2009
Cephalon Files Patent Infringement Lawsuit Against Teva Pharmaceuticals
Biopharmaceuticals Generics Litigation FDA
 HSMN NewsFeed - 2 Dec 2009
Elite Pharmaceutics and ThePharmaNetwork Announce FDA Approval for Generic Methadone Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 2 Dec 2009
AEterna Zentaris' Anti-Cancer Compound, Perifosine (KRX-0401), Receives FDA Fast Track Designation for the Treatment of Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Dec 2009
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Dec 2009
FDA Approves Use of Roche Test to Screen Source Plasma for HIV, Hepatitis B Virus and Hepatitis C Virus
Diagnostics FDA
 HSMN NewsFeed - 1 Dec 2009
Dyax Announces FDA Approval of KALBITOR(R) (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Dec 2009
FDA Approves ZEGERID OTC(TM) for Over-the-Counter Treatment of Frequent Heartburn
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Dec 2009
New Drug Application Submitted to FDA for Tapentadol Extended Release Tablets for Management of Chronic Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Dec 2009
Masimo Receives FDA Clearance for Masimo Rainbow SET(R) Acoustic Respiration Rate Monitoring
Devices Monitoring FDA
 HSMN NewsFeed - 30 Nov 2009
FDA Grants Orphan Drug Designation for 3,4-DAP for LEMS
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Nov 2009
Depomed Files Patent Infringement Lawsuit Against Lupin Limited
Biopharmaceuticals Generics Litigation FDA
 HSMN NewsFeed - 30 Nov 2009
FDA Approves Cymbalta(R) for Maintenance Treatment of Generalized Anxiety Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Nov 2009
Theravance Receives Complete Response Letter on the Telavancin NDA for the Treatment of Nosocomial Pneumonia
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Nov 2009
U.S. Food And Drug Administration (FDA) Grants Traditional Approval for INTELENCE(R) (etravirine)
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 23 Nov 2009
DGIMED Receives FDA Clearance on IM Nail System
Devices Orthopaedic FDA
 HSMN NewsFeed - 23 Nov 2009
ARCA Receives FDA Fast Track Designation for Gencaro(TM) Development in Genotype-Defined Heart Failure Population
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 20 Nov 2009
Pfizer Receives FDA Approval For Geodon(R) (Ziprasidone HCI) Capsules For The Adjunctive Maintenance Treatment Of Bipolar Disorder In Adults
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2009
Boston Scientific Announces FDA Clearance and CE Mark for WallFlex(R) Fully Covered Esophageal Stent
Devices Interventional Gastroenterology FDA
 HSMN NewsFeed - 20 Nov 2009
FDA Approves Intravenous Formulation Of Pfizer's Revatio(R) (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2009
FDA Extends Review of NDA for Exalgo
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Nov 2009
BSD Medical Corporation Reports Continuation of FDA Review of BSD-2000 Hyperthermia System
Devices Oncology FDA
 HSMN NewsFeed - 18 Nov 2009
StemCells, Inc. Provides Update on NCL Program Meeting with FDA
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 18 Nov 2009
Medtronic Receives FDA Warning Letter Following Inspection of Its Mounds View, Minn. Facility
Devices FDA
 HSMN NewsFeed - 17 Nov 2009
Genentech Submits Supplemental Applications to FDA for Avastin Combined with Commonly Used Chemotherapies for Women with Advanced Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Nov 2009
OSI Pharmaceuticals Announces Tarceva to Be Reviewed by the FDA's Oncologic Drugs Advisory Committee for Use as a First-Line Maintenance Therapy in Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Nov 2009
Covidien Introduces First FDA-Approved Spine Sealant
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 10 Nov 2009
Depomed Receives Notice of Paragraph IV Certification Against Patents for GLUMETZA(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 Nov 2009
Spine Now, LLC Announces FDA 510(k) Approval of maxMorespine System(R) and USA Distribution Alliance with Hoogland Spine Products GmbH
Devices Orthopaedic Neurosurgery Distribution FDA
 HSMN NewsFeed - 9 Nov 2009
Onset Medical Receives U.S. FDA Marketing Clearance for the SoloPath TransFemoral Endovascular Access Catheter
Devices Interventional FDA
 HSMN NewsFeed - 9 Nov 2009
Wright Medical Group, Inc. Receives FDA Approval to Market CONSERVE(R) Plus Total Hip Resurfacing System
Devices Orthopaedic FDA
 HSMN NewsFeed - 9 Nov 2009
Vascular Solutions Announces 510(k) Clearance and U.S. Launch of GuideLiner Catheter
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 5 Nov 2009
Custom Spine Receives 510k Clearance of Regent ACP
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 5 Nov 2009
ABRAXANE(R) Receives Orphan Drug Status for the Treatment of Pancreatic Cancer and Stage IIB-IV Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Nov 2009
NovaRx Corporation Announces FDA Approval of Protocol Amendment to Special Protocol Assessment (SPA) for Phase III Lucanix(R) Study in Non-Small Cell Lung Cancer (NSCLC)
Biopharmaceuticals Oncology FDA
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