Healthcare Sales & Marketing Network: FDA : Medical Device and Pharmaceutical News

Healthcare News Roundup: FDA

HSMN NewsFeed - 14 Sep 2007
Bausch & Lomb Boston(R) XO2 Gas Permeable Lens Material Gains FDA Clearance for Daily Wear
Devices FDA Ophthalmology

HSMN NewsFeed - 14 Sep 2007
FDA Accepts NDA Filing for Cleviprex(TM) (Clevidipine Butyrate Injectable Emulsion) for the Treatment of Acute Hypertension
Biopharmaceuticals

HSMN NewsFeed - 14 Sep 2007
FDA Approves Lilly's Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 13 Sep 2007
FDA To Continue Its Review of Requests for Release of Clinical Hold on alvimopan (Entereg(R))
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Sep 2007
FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Sep 2007
Vision-Sciences, Inc. Receives FDA Clearance to Market the World's First Video-Based Advanced Endoscopy Lines for Use With its New Generation EndoSheath Technology
Devices FDA

HSMN NewsFeed - 12 Sep 2007
FDA Advisory Panel to Review Medtronic's Endeavor Drug Eluting Stent on October 10
Devices Interventional Cardiology FDA

HSMN NewsFeed - 11 Sep 2007
Ortho Biotech Supports FDA Advisory Committees' Recommendations on Use of ESAs in Chronic Renal Failure Patients
Biopharmaceuticals

HSMN NewsFeed - 11 Sep 2007
Corcept Therapeutics Receives FDA Notification Opening IND for CORLUX(R) for the Treatment of Cushing's Syndrome
Biopharmaceuticals

HSMN NewsFeed - 11 Sep 2007
Amgen to Review Benefits, Risks of ESA Therapy in Chronic Renal Failure Patients at FDA Advisory Committee
Biopharmaceuticals

HSMN NewsFeed - 11 Sep 2007
BioSante Pharmaceuticals Announces FDA Clarity on Development of LibiGel(R) (Transdermal Testosterone Gel) in the Treatment of Female Sexual Dysfunction
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Sep 2007
Accuray Receives FDA Clearance for New Dose Calculation Technique for Body Radiosurgery
Devices Oncology FDA

HSMN NewsFeed - 10 Sep 2007
BrainStorm Cell Therapeutics Takes Initial Steps Toward FDA Submission
Regenerative Medicine Neurology

HSMN NewsFeed - 10 Sep 2007
ARIAD Announces Agreement with FDA on Special Protocol Assessment for Phase 3 Clinical Trial of Oral Deforolimus
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Sep 2007
Mylan Announces Tentative FDA Approval for Topiramate Capsules
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 10 Sep 2007
Bioniche Reaches Special Protocol Assessment Agreement with U.S. FDA for Phase III Comparative Bladder Cancer Trial
Biopharmaceuticals Oncology Urology FDA

HSMN NewsFeed - 10 Sep 2007
FDA Informs Endo and Vernalis That New Target Action Date on Frova(R) sNDA Is Sept. 30, 2007
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Sep 2007
Mylan Announces Final FDA Approval for Carvedilol Tablets
Biopharmaceuticals Cardiology Generics FDA

HSMN NewsFeed - 5 Sep 2007
Encysive Pharmaceuticals Receives Written Response From FDA On Its Request for Formal Dispute Resolution for THELIN (Sitaxsentan Sodium)
Biopharmaceuticals

HSMN NewsFeed - 5 Sep 2007
FDA Advisory Committee Unanimously Recommends Accelerated Approval of ISENTRESS(TM) (raltegravir), Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV
Biopharmaceuticals HIV/AIDS FDA

HSMN NewsFeed - 5 Sep 2007
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
Biopharmaceuticals Cardiology Generics FDA

HSMN NewsFeed - 5 Sep 2007
NovoSci Receives FDA Clearance for Hemodialysis Catheters
Devices FDA

HSMN NewsFeed - 5 Sep 2007
Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 5 Sep 2007
Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 4 Sep 2007
GTC Obtains FDA Fast Track Designation for ATryn(R) and Permission to Submit a Rolling BLA
Biopharmaceuticals FDA

HSMN NewsFeed - 30 Aug 2007
Somatuline(R) Depot Receives FDA Marketing Approval for the Treatment of Acromegaly
Biopharmaceuticals FDA

HSMN NewsFeed - 30 Aug 2007
YM BioSciences USA cleared by US FDA to initiate Phase II clinical trial of nimotuzumab in children with inoperable, recurrent brain cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Aug 2007
Abiomed Receives Conditional FDA Approval for Impella 2.5 Pivotal Study at up to 150 Hospitals
Devices Cardiology

HSMN NewsFeed - 29 Aug 2007
FDA Grants Orphan Drug Designation to TREANDA, an Investigational Treatment for Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Aug 2007
Merck Announces FDA Acceptance of NDA for CORDAPTIVE(TM) (ER niacin/laropiprant), Formerly Known as MK-0524A, an Investigational Lipid-Modifier
Biopharmaceuticals

HSMN NewsFeed - 29 Aug 2007
Hemo-Stream(TM) Chronic Dialysis Catheter Receives FDA Clearance
Devices FDA

HSMN NewsFeed - 28 Aug 2007
FDA Approves New Roche West Nile Virus Blood Screening Test
Diagnostics FDA

HSMN NewsFeed - 28 Aug 2007
FDA Accepts for Review Complete Response to Approvable Letter for Entereg(R) (alvimopan) for POI
Biopharmaceuticals Surgery FDA

HSMN NewsFeed - 28 Aug 2007
Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Aug 2007
Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 24 Aug 2007
AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
Devices Interventional FDA Regulatory

HSMN NewsFeed - 23 Aug 2007
RTX Healthcare Receives FDA 510k Market Clearance for Telehealth Monitor
Devices Monitoring FDA

HSMN NewsFeed - 22 Aug 2007
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 22 Aug 2007
FDA Approves RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Aug 2007
U.S. FDA Approves GE Healthcare's Newest Mobile Mammography System for Improved Access to Breast Care
Devices Radiology Oncology FDA

HSMN NewsFeed - 21 Aug 2007
MMDI’s Rebound HRD(tm) Receives FDA 510(k) Clearance
Devices FDA

HSMN NewsFeed - 21 Aug 2007
FDA Advisory Panel to Review Medtronic's Endeavor Drug Eluting Stent in October
Devices Interventional Cardiology FDA

HSMN NewsFeed - 21 Aug 2007
Watson Receives FDA Approval For Generic Duragesic(R)
Biopharmaceuticals FDA Generics Drug Delivery

HSMN NewsFeed - 21 Aug 2007
DJO Incorporated Receives FDA Market Approval for Enhanced Patient Features for Its Line of OL1000 and SpinaLogic(R) Bone Growth Stimulation Products
Devices Orthopaedic FDA

HSMN NewsFeed - 20 Aug 2007
Varian Medical Systems Receives FDA 510(k) Clearance for Smart Segmentation(TM) Tool That Dramatically Speeds Up Radiotherapy Treatment Planning
Devices FDA Oncology

HSMN NewsFeed - 20 Aug 2007
Solvay Pharmaceuticals, Inc. Receives Approvable Letter from FDA with Respect to New Drug Application for CREON(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Aug 2007
IsoTis Receives FDA Clearance for Accell Family of Products
Devices Orthopaedic FDA

HSMN NewsFeed - 20 Aug 2007
Nexavar Granted FDA Priority Review for Treatment of Liver Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 20 Aug 2007
FDA Grants Tikvah Therapeutics, Inc. Orphan Drug Status for Sodium Phenylbutyrate for the Treatment of Spinal Muscular Atrophy
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Aug 2007
Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Aug 2007
Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Aug 2007
Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 16 Aug 2007
ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 15 Aug 2007
Thoratec Announces HeartMate II(R) PMA Will be Reviewed by FDA Advisory Panel
Devices Cardiology FDA

HSMN NewsFeed - 13 Aug 2007
Sciele Pharma and Lifecycle Pharma Announce FDA Approval of New Formulation of Fenofibrate in 120 Mg. and 40 Mg. Dosage Strengths
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 10 Aug 2007
Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Aug 2007
Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Aug 2007
Mylan Announces Final FDA Approval for Verapamil Hydrochloride Extended-Release Capsules (PM)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 10 Aug 2007
FDA Grants Additional Six Months Marketing Exclusivity for the High Blood Pressure Medicine Diovan(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Aug 2007
GeneraMedix Inc. Announces FDA Approval and Launch of Ampicillin and Sulbactam for Injection, USP
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 9 Aug 2007
Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
Diagnostics HIV/AIDS FDA

HSMN NewsFeed - 9 Aug 2007
FDA Clears Unique Non-Invasive, Radiation-Free Pulmonary Imaging System
Devices FDA

HSMN NewsFeed - 8 Aug 2007
GSK Receives Decision From FDA on Advair(R) 500/50 for COPD
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Aug 2007
Syneron's Vela(TM) Platform Receives FDA Clearance for Temporary Reduction of Thigh Circumference
Devices Dermatology Regulatory FDA

HSMN NewsFeed - 8 Aug 2007
Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS
Biopharmaceuticals

HSMN NewsFeed - 7 Aug 2007
GammaCan Receives FDA Orphan Drug Designation for Lead Product VitiGam(TM) for Stage IIB to Stage IV Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Aug 2007
ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
Biopharmaceuticals FDA

HSMN NewsFeed - 7 Aug 2007
Lux Granted Fast Track Designation by FDA for LX211 for the Treatment of Uveitis
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 7 Aug 2007
Cook Medical Submits Final PMA Modules to FDA for Approval of the Cook Zenith TX2(R) Thoracic Aortic Aneurysm Endovascular Graft
Devices Interventional

HSMN NewsFeed - 7 Aug 2007
Abraxis BioScience Receives FDA Approval for Oxytocin Injection 10 USP Units/mL in a 30 mL Vial
Biopharmaceuticals Distribution

HSMN NewsFeed - 6 Aug 2007
Indevus Announces FDA Approval of SANCTURA(R) XR
Biopharmaceuticals Urology FDA

HSMN NewsFeed - 2 Aug 2007
FDA Issues Second Approvable Letter for Trexima(TM)
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Aug 2007
CryoCor Receives FDA Approval for Right Atrial Flutter
Devices Cardiology FDA

HSMN NewsFeed - 1 Aug 2007
Masimo Announces FDA Clearance for Additional Neonatal Parameters for Rainbow SET, Including Continuous and Noninvasive Measurement of Methemoglobin
Devices Monitoring FDA

HSMN NewsFeed - 1 Aug 2007
Genta and Emisphere Technologies File IND with FDA for Oral Drug to Treat Bone Disease
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 1 Aug 2007
InNexus Appoints FDA Expert Dr. Jur Strobos to Chief Medical Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 31 Jul 2007
Joint FDA Advisory Committee Recommends Approval of TYSABRI(R) for the Treatment of Moderate to Severe Crohn's Disease
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 31 Jul 2007
BSD Medical Files Response to FDA Questions on BSD-2000 PMA Submission Following Meeting with FDA
Devices Oncology FDA

HSMN NewsFeed - 31 Jul 2007
Endocrinologists Welcome FDA Avandia Recommendation
Biopharmaceuticals Endocrinology Cardiology FDA

HSMN NewsFeed - 31 Jul 2007
Accentia Biopharmaceuticals Files Pre-Investigational New Drug (IND) Application with FDA for Pivotal Phase 3 Clinical Trial of Revimmune for Refractory Multiple Sclerosis
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 31 Jul 2007
FDA Clears New GlucosePilot(TM) Blood Glucose Meter System
Devices Monitoring FDA Endocrinology

HSMN NewsFeed - 31 Jul 2007
FDA Advisory Panel Votes 22 to 1 for Avandia(R) to Remain Available to Patients in the US
Biopharmaceuticals Endocrinology Cardiology FDA

HSMN NewsFeed - 30 Jul 2007
ThermoGenesis Corp. Obtains FDA Clearance to Market CryoSeal(R) Fibrin Sealant (FS) in Liver Resection Surgeries
Devices FDA Surgery

HSMN NewsFeed - 30 Jul 2007
Medcool Inc. Receives FDA Clearance for Its RapidCool (TM) System
Devices FDA

HSMN NewsFeed - 30 Jul 2007
Cook Medical Receives FDA Clearance for Celect(TM) Vena Cava Filter
Devices Interventional FDA

HSMN NewsFeed - 30 Jul 2007
VIVUS Receives FDA Approval of Evamist NDA
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 30 Jul 2007
Cadence Pharmaceuticals Announces Agreement With FDA on Increased Enrollment In Phase III Clinical Trial of Omigard(TM)
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Jul 2007
Akorn, Inc. Announces FDA Approval of Ketotifen Fumarate Ophthalmic Solution, 0.025%
Biopharmaceuticals Ophthalmology Generics FDA

HSMN NewsFeed - 26 Jul 2007
St. Jude Medical Receives FDA Clearance for ACross Transseptal Access System
Devices Cardiology FDA

HSMN NewsFeed - 25 Jul 2007
FDA Classifies Baxter's Voluntary Recall Action Regarding Service Documentation as a Class I Recall
Devices Product Recall FDA

HSMN NewsFeed - 25 Jul 2007
Lutronic USA LLC Earns US FDA Clearance for MOSAIC Fractional Laser System
Devices Dermatology FDA

HSMN NewsFeed - 25 Jul 2007
FDA Approves Conceptus' Third Generation Essure(R) Permanent Birth Control System
Devices FDA

HSMN NewsFeed - 25 Jul 2007
FDA Accepts Innovative Drug Application - ImmunoMod Begins Diabetes Therapeutic Trials
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 25 Jul 2007
St. Jude Medical Announces FDA Clearance of the Proxis Embolic Protection System
Devices Interventional Cardiology FDA

HSMN NewsFeed - 25 Jul 2007
Antares Reaches Agreement with FDA on Special Protocol Assessment for Pivotal Trial of Anturol(TM)
Biopharmaceuticals Urology

HSMN NewsFeed - 24 Jul 2007
FDA Oncologic Drugs Advisory Committee Recommends that FDA Wait for Overall Survival Results from Satraplatin Phase 3 Trial
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 24 Jul 2007
Anika Therapeutics Receives FDA Approval for ELEVESS(TM) Product
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 24 Jul 2007
FDA Advisory Committee Recommends Approval of EVISTA for the Reduction of Risk for Invasive Breast Cancer in Two Populations of Postmenopausal Women
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 24 Jul 2007
Wyeth Receives Approvable Letter from FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated with Menopause
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Jul 2007
Neurochem granted Fast Track designation from U.S. FDA for tramiprosate (ALZHEMED(TM))
Biopharmaceuticals FDA Neurology

HSMN NewsFeed - 23 Jul 2007
QLT announces FDA filing and review of Aczone(TM) labeling supplement for removal of blood screening requirement
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 20 Jul 2007
Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Provigil(R)
Biopharmaceuticals Generics FDA

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