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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 - 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
Mylan Announces Tentative Approval for Valacyclovir Hydrochloride Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 31 Jan 2007
BIOLASE Announces FDA Clearance of Its ezlase(TM) Soft Tissue Diode Laser
Devices Dental FDA
 HSMN NewsFeed - 31 Jan 2007
Adeza Receives Orphan Drug Designation for Gestiva
Biopharmaceuticals 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
Light Sciences Oncology Receives Special Protocol Assessment for Pivotal Phase III Trial of Litx(TM) Therapy in Metastatic Colorectal Cancer
Devices Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Jan 2007
Gloucester Pharmaceuticals Receives Special Protocol Assessment for Pivotal Phase II Trial of Romidepsin in Patients with Peripheral T-Cell Lymphoma
Biopharmaceuticals Oncology FDA
 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 - 30 Jan 2007
Teva Receives Approval for Generic Focalin(TM) Tablets
Biopharmaceuticals Generics 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
Par Pharmaceutical Receives Approval of Generic Inderal-LA(R)
Biopharmaceuticals Cardiology Generics 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
Cytori Receives U.S. 510(K) Regulatory Clearance for its Adipose Tissue Processing System with Related Celase(TM) Reagent
Regenerative Medicine 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
Barr's Subsidiary PLIVA Receives Approval for Generic ZITHROMAX(R) IV, 500 mg Vial
Biopharmaceuticals Generics 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
FlowCardia, Inc. Announces 510(k) Clearance for the CROSSER(TM) 14 Chronic Total Occlusion Recanalization System
Devices Interventional FDA
 HSMN NewsFeed - 23 Jan 2007
Sanguine Receives FDA Meeting Minutes to Define PHER-O2 Regulatory Path
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Jan 2007
Vascular Solutions Announces 510(K) Clearance of New 023 Version of the Twin- Pass Dual Access Catheter
Devices Interventional 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
Generic Medical Devices Receives 510(k) Clearance for the GMD Universal Circumcision Clamp
Devices Surgery 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
Barr Receives Tentative Approval for Generic KYTRIL(R) Tablets, 1mg (Base)
Biopharmaceuticals Generics 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 - 18 Jan 2007
ZOLL Receives Marketing Clearance for E Series with Real CPR Help Technology
Devices Cardiology FDA
 HSMN NewsFeed - 17 Jan 2007
Roche Diagnostics Submits West Nile Virus Blood Screening Test to FDA
Diagnostics
 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
Hana Biosciences Receives Orphan Drug Designation for Marqibo(R) (Vincristine Sulfate Liposomes Injection) for the Treatment of Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Jan 2007
Tercica Reports Somatuline(R) Autogel(R) NDA for Acromegaly Accepted for Filing by FDA
Biopharmaceuticals 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
Roche Diagnostics Submits Hepatitis C Viral Load Monitoring Test to FDA
Diagnostics 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
AngioScore Receives Premarket Approval (PMA) for AngioSculpt(R) Scoring Balloon Catheter
Devices Interventional Cardiology FDA
 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
Vascular Solutions Announces 510(K) Clearance of InnerChange Micro-Introducer Catheter
Devices Interventional FDA
 HSMN NewsFeed - 8 Jan 2007
Xanthus Receives Orphan Drug Designation of Xanafide for the Treatment Of AML
Biopharmaceuticals FDA
 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
Victory Pharma, Inc. Announces Investigational New Drug MGX-006 Approved by the FDA
Biopharmaceuticals 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 - 4 Jan 2007
Advanced Medical Optics Updates Possible Timing for U.S. Launch of Tecnis(R) Multifocal Intraocular Lens
Devices Ophthalmology FDA
 HSMN NewsFeed - 3 Jan 2007
MedicalCV, Inc. to Amend 510(k) Submission of Its Automated Surgical Ablation System for Cardiac Tissue Ablation to Seek Soft Tissue Clearance
Devices FDA
 HSMN NewsFeed - 3 Jan 2007
Mylan's Levothyroxine Sodium Tablets USP Approved as Generic Equivalent to Levothroid(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 3 Jan 2007
Spectrum Pharmaceuticals Announces FDA's Acceptance of Ozarelix IND and Approval of Phase 2b Protocol in BPH (Benign Prostate Hypertrophy)
Biopharmaceuticals Urology
 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
Lupin Pharmaceuticals Announces Tentative Approval of Generic ZOLOFT(R)
Biopharmaceuticals Generics 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
OMRIX Biopharmaceuticals Files Investigational New Drug (IND) Application For Anti-Adhesion Product Candidate and Announces Recent Milestone Achievements
Biopharmaceuticals Surgery FDA
 HSMN NewsFeed - 27 Dec 2006
FDA Approves Radiesse(R) Facial Filler for Two New Aesthetic Indications
Devices Dermatology FDA
 HSMN NewsFeed - 27 Dec 2006
Dr. Reddy's Announces Final Approval of Ondansetron Tablets with 180-Days of Marketing Exclusivity
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 26 Dec 2006
Astellas Pharma US, Inc. Submits Supplemental New Drug Application For Antifungal Product MYCAMINE(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Dec 2006
Vascular Solutions Announces Approval of 'Pocket Protector' Indication for D-Stat Flowable Hemostat
Devices Cardiology FDA
 HSMN NewsFeed - 26 Dec 2006
Barr Confirms Generic Thalomid(R) Capsule, 50 mg and 100 mg Application
Biopharmaceuticals Generics Oncology FDA
 HSMN NewsFeed - 26 Dec 2006
Par Pharmaceutical Receives Approval for Ondansetron Orally Disintegrating Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 26 Dec 2006
Celgene Notified of ANDA Filing for Thalidomide
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 22 Dec 2006
FDA Approves BYETTA(R) (exenatide) Injection for Expanded Combination Use
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 22 Dec 2006
UCB Announces Positive Results From Two New Phase III Studies in Rheumatoid Arthritis and Provides Update on the Status of US Approval for CIMZIATM in the Treatment of Crohn's Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Dec 2006
Exforge(R) Receives US Regulatory Approval as a New and Highly Effective Treatment Option for Patients with High Blood Pressure
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Dec 2006
US Destination Therapy Trial Protocol Approved for VentrAssist(TM) LVAD
Devices Cardiology 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
Bentley Pharmaceuticals' Generic Simvastatin Approved for U.S. Market
Biopharmaceuticals FDA Generics
 HSMN NewsFeed - 21 Dec 2006
Perrigo Company Announces FDA Approval For Simvastatin Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 21 Dec 2006
Alfacell Corporation Files for U.S. Orphan Drug Designation for ONCONASE(R)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Dec 2006
Genzyme Files for Approval of Sevelamer Carbonate for Patients on Dialysis
Biopharmaceuticals 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
Colazal(R) Pediatric Indication Approved
Biopharmaceuticals Gastroenterology 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
Neurorecovery, Inc. Receives Orphan Drug Designation
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 20 Dec 2006
INVEGA(TM) Approved By FDA as New Treatment for Schizophrenia
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Dec 2006
Ascent Healthcare Receives 510(k) Clearance on Carter-Thomason CloseSure(R) System
Devices FDA
 HSMN NewsFeed - 20 Dec 2006
Labopharm submits response to approvable letter for once-daily Tramadol to FDA
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
Orphan Therapeutics Announces Rolling NDA Submission for LUCASSIN(TM) (terlipressin) to Treat Type 1 Hepatorenal Syndrome
Biopharmaceuticals FDA
 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
Anchen Announces Approval of Generic Version of Wellbutrin XL(R)
Biopharmaceuticals Generics 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
Genta Receives Non-Approvable Notice for Application of Genasense(R) in Patients With Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology 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
EPIX Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Dec 2006
Ranbaxy Is Granted Final Approval to Manufacture and Market Cefprozil Anti- Infective Tablets
Biopharmaceuticals Generics 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
Baxter Receives Conditional Approval for U.S. COLLEAGUE Infusion Pump Corrective Action Plan and Submits Updated 510(k) Pre-Market Notification
Devices 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
Barr Confirms Generic Thalomid(R) Capsule Application
Biopharmaceuticals Generics 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
Celgene Notified of ANDA Filing for Thalidomide
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 13 Dec 2006
Access Pharmaceuticals Receives MuGard(TM) Marketing Clearance From the FDA
Biopharmaceuticals Oncology 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
Cyclacel Submits IND of CYC116 an Aurora Kinase and VEGRF2 Inhibitor to Treat Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Dec 2006
FDA Accepts New Drug Application for SANCTURA XR(TM) Submitted by Indevus
Biopharmaceuticals Urology
 HSMN NewsFeed - 13 Dec 2006
Pozen Expects to Submit Revised Response to Trexima(TM) (Sumatriptan/Naproxen Sodium) Approvable Letter by Year End
Biopharmaceuticals FDA
 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
 HSMN NewsFeed - 8 Dec 2006
FDA Approves VELCADE(R) (Bortezomib) for Injection for Aggressive Form of Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Dec 2006
Medtronic Presents Data on Next Generation Endeavor(R) Drug-Eluting Stent at Special FDA Panel Meeting on DES Safety
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 8 Dec 2006
MedicalCV, Inc. Revises Timing Expectations for Commercial Launch of Minimally Invasive System
Devices Cardiology FDA
 HSMN NewsFeed - 8 Dec 2006
Rimonabant Update in the United States
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 7 Dec 2006
Tornier Receives FDA Clearance for the Salto Talaris(TM) Anatomic Ankle Prosthesis
Devices Orthopaedic FDA
 HSMN NewsFeed - 7 Dec 2006
Real-World Taxus(R) Stent Data Confirm Favorable Outcomes for Patients With Complex Coronary Artery Disease
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 7 Dec 2006
Data Presented To FDA Panel Show TAXUS Drug-Eluting Stents as Safe as Bare-Metal Stents and Far More Effective in Reducing Repeat Procedures
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 7 Dec 2006
Sorin Group: ELA Medical, Inc. Files PMA Submission for Ovatio(TM) CRT
Devices Cardiology FDA
 HSMN NewsFeed - 7 Dec 2006
Cardium's Generx Advances to Phase 3 Following Meeting With FDA
Biopharmaceuticals Cardiology
 HSMN NewsFeed - 7 Dec 2006
Cephalon Provides Update Related to Final NUVIGIL(TM) Labeling
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Dec 2006
Medarex Announces FDA Fast Track Designations for Ipilimumab for the Treatment of Metastatic Melanoma; Fast Track Designations for First-Line Use in Combination With Chemotherapy and Second-Line Use as Monotherapy
Biopharmaceuticals FDA Oncology
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