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Healthcare News Roundup: FDA

 HSMN NewsFeed - 3 Nov 2009
FDA Approves New Salix Product Exclusively in Catalent's Zydis(R) Fast Dissolve Technology
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 2 Nov 2009
Cardium Announces Plans to File FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Gel for Diabetic, Pressure and Venous Ulcers and Other Topical Wounds
Devices Wound Care
 HSMN NewsFeed - 29 Oct 2009
FDA Grants Emergency Use Authorization of the Prodesse ProFlu-ST(TM)
Diagnostics FDA
 HSMN NewsFeed - 29 Oct 2009
Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo(R) New Drug Application
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Oct 2009
FDA Issues Guidance for Derma Sciences' Exclusive Wound Dressing With pDADMAC
Devices Wound Care FDA
 HSMN NewsFeed - 28 Oct 2009
Ascent Healthcare Solutions Receives 510(K) Clearance to Reprocess Biosense Webster SoundStar 3D Diagnostic Ultrasound Catheter
Devices FDA
 HSMN NewsFeed - 28 Oct 2009
FDA Clears Interlace Medical's MyoSure(TM) Hysteroscopic Tissue Removal System for The Treatment of Submucosal Fibroids
Devices FDA
 HSMN NewsFeed - 27 Oct 2009
Lumenis Receives 510(k) Clearance for the PolyScope Disposable Flexible Endoscope
Devices FDA
 HSMN NewsFeed - 27 Oct 2009
AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Enterococcal Bloodstream Pathogens
Diagnostics FDA
 HSMN NewsFeed - 26 Oct 2009
Novel Cardio-Pulmonary Support Device LIFEBRIDGE(R) From Germany Gains FDA Clearance
Devices Cardiology FDA
 HSMN NewsFeed - 26 Oct 2009
FDA Determines VYVANSE(R) was Properly Granted Five-Year Market Exclusivity
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Oct 2009
Elekta's Radiosurgery Solutions on Center Stage at 2009 Congress of Neurological Surgeons Annual Meeting
Devices Oncology Neurosurgery FDA
 HSMN NewsFeed - 23 Oct 2009
Invatec Receives FDA Clearance for Mo.Ma(R) Ultra Proximal Cerebral Protection Device
Devices Interventional FDA
 HSMN NewsFeed - 21 Oct 2009
MacuSight(R) Receives Fast Track Designation From FDA for Perceiva(TM) in Treatment of Diabetic Macular Edema
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 21 Oct 2009
FDA Issues Complete Response Letter for CorVue(TM)
Biopharmaceuticals Cardiology Radiology FDA
 HSMN NewsFeed - 20 Oct 2009
FDA Approves New Test to Aid in the Diagnosis of Rheumatoid Arthritis
Diagnostics FDA
 HSMN NewsFeed - 19 Oct 2009
FDA Approves Colcrys(TM) (colchicine, USP) for Prevention of Gout Flares
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Oct 2009
Endo Pharmaceuticals Gives Update on Regulatory Status of FORTESTA(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Oct 2009
FDA Approves New Use for Micardis(R) in Cardiovascular Risk Reduction and Twynsta(R) as New Combination Treatment for High Blood Pressure
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 19 Oct 2009
Amgen Provides Update on Status of Prolia(TM) (Denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA)
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Oct 2009
Talecris Biotherapeutics Receives FDA Approval for PROLASTIN(R)-C
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Oct 2009
FDA Approves GARDASIL(R) for Use in Boys and Young Men
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Oct 2009
FDA Approves Elitek(R) (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Oct 2009
FDA Approves Cervarix, GlaxoSmithKline's Cervical Cancer Vaccine
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Oct 2009
Palomar to Commercialize FDA Cleared Over-The-Counter Home Use Wrinkle Treatment Laser Device Without Johnson & Johnson
Devices Dermatology Licensing
 HSMN NewsFeed - 15 Oct 2009
Biosense Webster Receives FDA Clearance for the CARTO(R) 3 System
Devices Cardiology FDA
 HSMN NewsFeed - 15 Oct 2009
Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 14 Oct 2009
Ortho Clinical Diagnostics Receives FDA Approval for First Anti-HIV 1+2 Test for Use on Random Access, Integrated Laboratory Testing System
Diagnostics FDA HIV/AIDS
 HSMN NewsFeed - 14 Oct 2009
Solos Endoscopy, Inc.'s FDA Approved MammoView(TM) Product Line to Obtain CE Mark
Devices Regulatory
 HSMN NewsFeed - 13 Oct 2009
Nanosphere Announces FDA 510(k) Clearance of the Verigene(R) SP and Respiratory Virus Nucleic Acid Test
Diagnostics FDA
 HSMN NewsFeed - 12 Oct 2009
Novartis Enters Into Agreement for Exclusive US and Canadian Rights to Fanapt(TM), an FDA-Approved Oral Therapy for Schizophrenia
Biopharmaceuticals Licensing
 HSMN NewsFeed - 12 Oct 2009
Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve
Devices FDA
 HSMN NewsFeed - 12 Oct 2009
RSB Spine, LLC, Announces FDA Clearance for the InterPlate(R) C-Ti as an Anterior Cervical Plate
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 12 Oct 2009
CSL Behring Announces FDA Approval of Berinert(R), First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Oct 2009
FDA Advisory Committee Recommends Approval of Pfizer's Selzentry for Use in Patients Starting HIV Therapy for the First Time
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 6 Oct 2009
CryoLife Receives Humanitarian Use Device Designation for SynerGraft(R) Processed Human Aortic Heart Valves
Devices Cardiology FDA
 HSMN NewsFeed - 5 Oct 2009
GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for VOTRIENT(TM)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 Oct 2009
FDA Advisory Committee Recommends Approval of PEGINTRON(R) for the Adjuvant Treatment of Stage III Malignant Melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 Oct 2009
SonoSite Announces FDA Clearance for Its New NanoMaxx Ultrasound Tool
Devices FDA
 HSMN NewsFeed - 5 Oct 2009
GE Healthcare Introduces CARESCAPE Monitor B850
Devices FDA Monitoring
 HSMN NewsFeed - 5 Oct 2009
Impax Laboratories Receives Tentative FDA Approval for Generic FLOMAX(R) 0.4mg Capsules
Biopharmaceuticals Urology Generics FDA
 HSMN NewsFeed - 1 Oct 2009
Given Imaging's PillCam(R) SB and Agile(TM) Patency System Cleared for Use in Young Children
Devices Gastroenterology FDA
 HSMN NewsFeed - 30 Sep 2009
Mylan Receives FDA Approval for Generic Version of Parkinson's Treatment Sinemet(R)
Biopharmaceuticals Generics Neurology FDA
 HSMN NewsFeed - 30 Sep 2009
Covidien Receives FDA Clearance for its Mallinckrodt TaperGuard Evac Endotracheal Tube
Devices FDA
 HSMN NewsFeed - 25 Sep 2009
Allos Therapeutics' FOLOTYN First and Only FDA-Approved Therapy for Relapsed or Refractory Peripheral T-cell Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Sep 2009
Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Sep 2009
MedShape Solutions, Inc. Announces First FDA-cleared Shape Memory PEEK Device; Closing of $10M Equity Offering
Devices FDA Orthopaedic
 HSMN NewsFeed - 22 Sep 2009
FDA Clears Sysmex XE-2100D Hematology Analyzer for Blood Processing Center Quality Control Release Testing
Diagnostics FDA
 HSMN NewsFeed - 21 Sep 2009
Abbott Receives FDA Approval for First Fully Automated Blood Screening Test for HIV-1/HIV-2
Diagnostics HIV/AIDS FDA
 HSMN NewsFeed - 21 Sep 2009
Neuralstem Receives FDA Approval to Commence First ALS Stem Cell Trial
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 18 Sep 2009
FDA Grants Priority Review Status to Supplement Containing Long-Term Survival Data for VELCADE(R) (bortezomib) for Injection
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 17 Sep 2009
Medifocus, Inc. Files Response to its Investigational Device Exemption (IDE) With the Food and Drug Administration (FDA) in the United States for its Pivotal Phase III Clinical Trial for Treatment of Breast Cancer
Devices Oncology FDA
 HSMN NewsFeed - 16 Sep 2009
SpectraScience Receives FDA Approval for Enhancements to WavSTAT(R) Optical Biopsy System
Devices Diagnostics FDA
 HSMN NewsFeed - 16 Sep 2009
Sirion Therapeutics Announces FDA Approval of Zirgan(TM) (Ganciclovir Ophthalmic Gel) 0.15% for Herpetic Keratitis
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 16 Sep 2009
Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Sep 2009
Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 15 Sep 2009
Hansen Medical Unveils Next Generation Robotic Catheter System and Two New Catheters Offering Advanced Navigation Within the Heart
Devices Cardiology FDA
 HSMN NewsFeed - 14 Sep 2009
FDA Classifies Voluntary Notification Related to SC Catheters and IsoMed Pump Incompatibility as Class I Recall
Devices Product Recall
 HSMN NewsFeed - 14 Sep 2009
Wright Medical Group, Inc. Announces FDA Clearance for PRO-STIM Osteoinductive Bone Graft Substitute
Devices Orthopaedic FDA
 HSMN NewsFeed - 14 Sep 2009
St. Jude Medical Announces FDA Approval of EnSite Velocity Cardiac Mapping System
Devices Cardiology FDA
 HSMN NewsFeed - 14 Sep 2009
GENova Biotherapeutics prepares a 510(k) submission to the FDA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Sep 2009
FDA Issues Complete Response Letter For Trabectedin Combined With DOXIL
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Sep 2009
Par Pharmaceutical Receives Final Approval To Market Generic Starlix(R)
Biopharmaceuticals Generics Endocrinology FDA
 HSMN NewsFeed - 9 Sep 2009
FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine
Biopharmaceuticals Oncology FDA
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