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

Healthcare News Roundup: FDA

HSMN NewsFeed - 2 Feb 2007
FDA Approves New Dosing Recommendations for RAPAMUNE in High Immunologic Risk Renal Transplant Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Feb 2007
BDSI Announces FDA Acceptance of Bioral(R) Amphotericin IND
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 2 Feb 2007
DRAXIS Radiopharmaceuticals Division Applies to FDA to Market Cardiac Imaging Product
Biopharmaceuticals Generics Radiology

HSMN NewsFeed - 1 Feb 2007
Grifols Announces FDA Approval of Alphanate(R) to Treat von Willebrand Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Feb 2007
Ranbaxy Receives Final FDA Approval to Manufacture and Market Valacyclovir HCl Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 1 Feb 2007
Cardinal Health Complies With New FDA Glove Rule Two Years Ahead of Deadline
Devices

HSMN NewsFeed - 1 Feb 2007
Aastrom Receives Orphan Drug Designation from FDA for Dilated Cardiomyopathy
Regenerative Medicine Cardiology FDA

HSMN NewsFeed - 31 Jan 2007
Ranbaxy Gains FDA Approval to Market Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 31 Jan 2007
FDA Advisory Committee to Review DOR BioPharma's orBec(R) for the Treatment of GI GVHD
Biopharmaceuticals FDA

HSMN NewsFeed - 31 Jan 2007
Mylan Announces Final FDA Approval for Its 12 mcg/hr Fentanyl Transdermal System
Biopharmaceuticals Drug Delivery Generics FDA

HSMN NewsFeed - 31 Jan 2007
BIOLASE Announces FDA Clearance of Its ezlase(TM) Soft Tissue Diode Laser
Devices Dental FDA

HSMN NewsFeed - 30 Jan 2007
FDA Approves Possis Spiroflex(R) Catheter for Coronary Blood Clot Removal
Devices Interventional FDA

HSMN NewsFeed - 30 Jan 2007
AVANIR Receives FDA Approvable Letter for New Formulation of Currently Marketed Antipsychotic Drug FazaClo
Biopharmaceuticals FDA

HSMN NewsFeed - 30 Jan 2007
CardioTech Reports Clinical Trial is Underway for CardioPass(TM) After Receipt of FDA Export License for Synthetic Coronary Bypass Graft
Devices Cardiology

HSMN NewsFeed - 30 Jan 2007
Mylan Announces Final FDA Approval for Albuterol Sulfate Extended-Release Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 30 Jan 2007
Javelin Pharmaceuticals Announces Results of FDA Meeting for Nasal Ketamine
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 30 Jan 2007
Varian Medical Systems Receives FDA 510(k) Clearance for Technology that Monitors a Patient's Position during Radiotherapy and Radiosurgery
Devices Oncology FDA

HSMN NewsFeed - 30 Jan 2007
SpectRx, Inc. Holds Pre-PMA Meetings with FDA on Painless Cervical Cancer Test
Devices Diagnostics Oncology FDA

HSMN NewsFeed - 29 Jan 2007
Pharmion Corporation Announces FDA Approval of Vidaza NDA Supplement for IV Administration
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Jan 2007
Nephros Receives Conditional Approval from the FDA of Investigational Device Exemption Application
Devices FDA

HSMN NewsFeed - 29 Jan 2007
FDA Grants Boston Scientific Clearance to Expand PolarCath(TM) Peripheral Dilatation System Offering with New Balloon Length
Devices Interventional FDA

HSMN NewsFeed - 29 Jan 2007
Novadaq imaging system receives FDA clearance for use during plastic reconstructive surgery
Devices Surgery

HSMN NewsFeed - 29 Jan 2007
FDA Approves New Indication for YAZ(R) to Treat Acne
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 25 Jan 2007
Fujirebio Diagnostics Receives FDA Approval for the MESOMARK(R) Assay for the Management of Mesothelioma Patients
Diagnostics Oncology FDA

HSMN NewsFeed - 25 Jan 2007
FDA Clears BioView Duet(TM) System for Automated FISH Scanning of Breast Cancer Tissue Specimens
Diagnostics Oncology FDA

HSMN NewsFeed - 24 Jan 2007
ev3 Inc. Announces US FDA Approval of PROTEGE(R) RX Carotid Stent
Devices Interventional FDA

HSMN NewsFeed - 24 Jan 2007
Ikonisys Receives FDA Clearance for Automated Bladder Cancer Test
Devices Diagnostics Oncology FDA

HSMN NewsFeed - 23 Jan 2007
Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Jan 2007
Stiefel Laboratories Receives FDA Approval of Olux-E (Clobetasol Propionate) Foam, 0.05% for Treatment of Psoriasis and Eczema
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 23 Jan 2007
Sanguine Receives FDA Meeting Minutes to Define PHER-O2 Regulatory Path
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Jan 2007
Ortho Biotech Seeks FDA Approval for DOXIL(R) in Combination with VELCADE(R) to Treat Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Jan 2007
Sequella Receives FDA Fast Track Status for TB Drug
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Jan 2007
iCo Therapeutics Receives FDA Clearance to Initiate Clinical Trial in Diabetic Macular Edema
Biopharmaceuticals Endocrinology Ophthalmology FDA

HSMN NewsFeed - 22 Jan 2007
FDA Approves Orthovita's PMA Supplement for the CELLPAKER(R) Plasma Collection System Used in Conjunction with the VITAGEL(R) Surgical Hemostat
Devices FDA

HSMN NewsFeed - 22 Jan 2007
Innocoll Receives FDA Approval to Commence a Phase 2 Clinical Trial for the Topical Treatment of Infected Diabetic Foot Ulcers with Its CollaRx(R) GENTAMICIN
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Jan 2007
BioMS Medical cleared by FDA to initiate pivotal phase III multiple sclerosis trial
Biopharmaceuticals Neurology

HSMN NewsFeed - 19 Jan 2007
Bioptigen Receives FDA Clearance and Two Phase II SBIR Awards; Company to Exhibit at Major Technology Conference
Devices Ophthalmology

HSMN NewsFeed - 18 Jan 2007
Carl Zeiss Meditec Announces FDA Clearance to Market VISUMAX Femtosecond Laser System
Devices Ophthalmology FDA

HSMN NewsFeed - 18 Jan 2007
FDA Approves 18-Month Shelf Life for TAXUS(R) Stent System
Devices Interventional Cardiology FDA

HSMN NewsFeed - 18 Jan 2007
Ventana Receives FDA Approval for Rabbit Monoclonal Antibody
Diagnostics Oncology FDA

HSMN NewsFeed - 17 Jan 2007
Visiogen, Inc. Receives FDA Approval to Expand its U.S. Clinical Trial
Devices Ophthalmology FDA

HSMN NewsFeed - 16 Jan 2007
FDA Approves LIALDA(TM) (mesalamine), the First Oral Once-Daily Mesalamine for Patients With Active, Mild to Moderate Ulcerative Colitis
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 16 Jan 2007
FDA Clears Way for Innovative Acne Treatment Device
Devices Dermatology FDA Venture Capital

HSMN NewsFeed - 16 Jan 2007
CEL-SCI Receives Green Light From FDA to Proceed With Phase III Cancer Study
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Jan 2007
Vicus Therapeutics Announces the FDA has Allowed the Phase 2 Trial of VT-122 for the Treatment of Cachexia in Patients With Advanced Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Jan 2007
Applied Spine Technologies Receives Permission From FDA to Commence Pivotal Clinical Trial of Its Flagship Product, Stabilimax NZ(TM) Dynamic Spine Stabilization System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 16 Jan 2007
Aradigm Receives FDA Orphan Drug Designation for Liposomal Ciprofloxacin for Bronchiectasis
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Jan 2007
Lux Biosciences Receives Orphan Drug Designation from the FDA for Two Ophthalmic Products
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 15 Jan 2007
FDA Accepts for Filing a New Drug Application (NDA) for Somatuline(R) Autogel(R)
Biopharmaceuticals

HSMN NewsFeed - 11 Jan 2007
Synovis Life Technologies Granted Important FDA Indication and U.S. Patent for Veritas(R) Collagen Matrix
Devices FDA

HSMN NewsFeed - 11 Jan 2007
St. Jude Medical Announces FDA Clearance and European Approval of New Electrophysiology Products
Devices Cardiology FDA Regulatory

HSMN NewsFeed - 11 Jan 2007
FDA Clears Humanetics' IND Filing to Commence Clinical Studies on New Radiation Countermeasure
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Jan 2007
GenVec Receives Clearance From FDA for EUS Administration of TNFerade(TM)
Biopharmaceuticals Oncology FDA Drug Delivery

HSMN NewsFeed - 10 Jan 2007
GenesisBPS Announces the North American Distribution and FDA 510K Clearance of the SEPAX Cell Separation System for Cord Blood Processing
Devices FDA

HSMN NewsFeed - 10 Jan 2007
Vidacare's EZ-IO(R) Product System Receives FDA Clearance for Distal Tibia Access
Devices FDA

HSMN NewsFeed - 10 Jan 2007
Cell Therapeutics, Inc. (CTI) Files for Special Protocol Assessment (SPA) With FDA for XYOTAX Lung Cancer Trial in Women
Biopharmaceuticals Oncology

HSMN NewsFeed - 9 Jan 2007
Anthera Receives IND Approval from FDA to Begin Phase 2 'IMPACTS' Trial With A-001 for Prevention of Acute Chest Syndrome in Patients with Sickle Cell Disease
Biopharmaceuticals

HSMN NewsFeed - 8 Jan 2007
VIASYS Receives FDA Approval to Market Its PulmoLife(TM) Spirometry Screener
Devices FDA

HSMN NewsFeed - 8 Jan 2007
Osiris Therapeutics Receives FDA Fast Track Status for Its Crohn's Disease Stem Cell Therapy and Clearance to Start Phase III Clinical Trial
Regenerative Medicine Gastroenterology

HSMN NewsFeed - 8 Jan 2007
FDA Approves MedImmune's Refrigerated Formulation of FluMist(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Jan 2007
Provectus Receives Orphan Drug Designation from FDA for Anti-Cancer Agent PV-10 for the Treatment Of Metastatic Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 Jan 2007
Horizon Therapeutics Announces Special Protocol Assessment With FDA for Phase 3 Trial Program
Biopharmaceuticals

HSMN NewsFeed - 5 Jan 2007
Innovasis Announces Successful FDA Clearance for the 'PEEK Box' VBR System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 4 Jan 2007
INNOVIVE Pharmaceuticals Announces Receipt of FDA Orphan Drug Designation for INNO-406 for the Treatment of Chronic Myelogenous Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Jan 2007
Anthera Receives FDA Approval to Begin Phase 2 'PLASMA' Trial With A-002 for Patients With Coronary Atherosclerosis
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 3 Jan 2007
Third Wave Submits 510(k) to FDA for InPlex(TM) Cystic Fibrosis Molecular Test
Diagnostics

HSMN NewsFeed - 3 Jan 2007
FDA Approves BYETTA(R) (exenatide) Injection for Expanded Combination Use
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 2 Jan 2007
Graceway Pharmaceuticals, LLC Announces Completed Acquisition of 3M Pharmaceuticals Business and FDA Extension of Aldara Exclusivities
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 2 Jan 2007
Ranbaxy Granted Final U.S. FDA Approval to Manufacture and Market Atenolol Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 29 Dec 2006
Nuvo receives approvable letter from U.S. FDA for Pennsaid
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Dec 2006
Boca Pharmacal Receives FDA Approval for Generic Pamine(R) and Pamine(R) Forte Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 27 Dec 2006
FDA Approves Radiesse(R) Facial Filler for Two New Aesthetic Indications
Devices Dermatology FDA

HSMN NewsFeed - 22 Dec 2006
FDA Approves BYETTA(R) (exenatide) Injection for Expanded Combination Use
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 21 Dec 2006
Allergan Announces FDA Issues Approvable Letter for COMBIGAN(TM) (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 21 Dec 2006
Perrigo Company Announces FDA Approval For Simvastatin Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 21 Dec 2006
Ranbaxy Granted Final FDA Approval to Market Simvastatin 5, 10, 20 and 40 mg Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 21 Dec 2006
Anika Therapeutics Receives FDA Approval for Its Cosmetic Tissue Augmentation Product
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 21 Dec 2006
Natus Medical Receives FDA Approval for the Olympic Cool-Cap
Devices FDA Neurology

HSMN NewsFeed - 20 Dec 2006
Abiomed Announces FDA 510(k) Clearance for New Intra-Aortic Balloon and Development of Integrated Console, the iPulse, for the Balloon, BVS 5000 and AB5000
Devices Cardiology FDA

HSMN NewsFeed - 20 Dec 2006
FDA Approves New Indication for INVANZ(R) (ertapenem) for the Prevention of Surgical Site Infections (SSI) following Elective Colorectal Surgery in Adults
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Dec 2006
FDA Approves Orphan Drug Designation for SIGA's Smallpox Drug, SIGA-246
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Dec 2006
INVEGA(TM) Approved By FDA as New Treatment for Schizophrenia
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Dec 2006
Atrium Medical Receives FDA Approval for its ClearWay(TM) RX Therapeutic Perfusion Catheter
Devices Interventional FDA

HSMN NewsFeed - 19 Dec 2006
FDA Grants Torisel NDA Priority Review Status
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Dec 2006
Bradley Pharmaceuticals Announces FDA Approval of Elestrin(TM) (estradiol gel 0.06%)
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Dec 2006
Endo Pharmaceuticals Submits Citizen Petition to FDA Regarding Lidoderm(R)
Biopharmaceuticals Drug Delivery Generics FDA

HSMN NewsFeed - 18 Dec 2006
Gilead Submits New Drug Application To U.S. FDA for Ambrisentan for the Treatment of Pulmonary Arterial Hypertension
Biopharmaceuticals

HSMN NewsFeed - 18 Dec 2006
FDA Approves Next-Generation Possis AngioJet(R) System
Devices Interventional FDA

HSMN NewsFeed - 18 Dec 2006
Antares Receives First FDA Approval of ATD(TM) Gel Platform
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Dec 2006
FDA Approves Cyanokit(R) for Treatment of Cyanide Poisoning
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Dec 2006
FDA Maintains Clinical Hold on VaxGen's Anthrax Vaccine Trial
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Dec 2006
IMPAX Announces FDA Approval of Generic Wellbutrin XL 300 mg
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 18 Dec 2006
BioSante Pharmaceuticals Receives FDA Approval of Bio-E-Gel(R) (estradiol gel), to be Marketed as Elestrin(TM)
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Dec 2006
ZymoGenetics Submits Biologics License Application to the FDA for rhThrombin as an Aid to Controlling Bleeding During Surgery
Biopharmaceuticals

HSMN NewsFeed - 18 Dec 2006
SkyePharma PLC announces FDA approves FORADIL(R) CERTIHALER(TM)
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Dec 2006
Elan and Biogen Idec Submit Supplemental Biologics License Application to the FDA for the Approval of TYSABRI(R) as a Treatment for Crohn's Disease
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 15 Dec 2006
CellSearch(TM) Circulating Tumor Cell Kit Receives FDA Clearance for Monitoring Patients with Metastatic Breast Cancer
Diagnostics Oncology FDA

HSMN NewsFeed - 15 Dec 2006
Roche Offers the FDA Additional MIRCERA(R) Data
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Dec 2006
FilterWire EZ(TM) Embolic Protection System Cleared By FDA For Carotid Artery Stenting
Devices Interventional FDA

HSMN NewsFeed - 14 Dec 2006
Response Biomedical Files for US FDA 510k Market Clearance of RAMP NT-proBNP Test for the Diagnosis of Congestive Heart Failure
Diagnostics Cardiology FDA

HSMN NewsFeed - 14 Dec 2006
Jenken Biosciences Receives FDA Clearance for Phase II Trial of Lead Compound
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Dec 2006
Ortho-Clinical Diagnostics Receives FDA Approval for First Blood-Screening Test for Chagas' Disease
Diagnostics FDA

HSMN NewsFeed - 13 Dec 2006
CoAxia(TM) Announces FDA Approval of Clinical Trial for Its Novel Stroke Treatment in Patients up to 24 Hours After Onset
Devices Neurology Interventional FDA

HSMN NewsFeed - 13 Dec 2006
Reliant Pharmaceuticals Submits New Data to FDA Supporting Use of Omacor(R) (Omega-3-Acid Ethyl Esters) With a Statin to Reduce High Triglycerides
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Dec 2006
FDA Accepts New Drug Application for SANCTURA XR(TM) Submitted by Indevus
Biopharmaceuticals Urology

HSMN NewsFeed - 12 Dec 2006
Biomira receives special protocol assessment from the FDA for Phase III trial of Stimuvax for non-small cell lung cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 12 Dec 2006
Medicure Announces Special Protocol Assessment With the FDA For Phase III MEND-CABG II Study
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 12 Dec 2006
VIVUS Announces FDA Acceptance of EvaMist(TM) NDA Submission
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Dec 2006
CryoLife Receives FDA 510(k) Clearance for ProPatch(TM) Soft Tissue Repair Matrix
Devices FDA

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