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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 - 24 May 2007
FDA Approves Gen-Probe's Automated PROCLEIX(R) TIGRIS(R) System to Test Donated Blood With the PROCLEIX ULTRIO(R) Assay
Diagnostics FDA
 HSMN NewsFeed - 24 May 2007
GE Healthcare Receives FDA Clearance for CARESCAPE Patient Data Module for Mobile Patient Monitoring
Devices FDA Monotoring
 HSMN NewsFeed - 24 May 2007
BioMarin Submits New Drug Application for U.S. Marketing Authorization of Kuvan for Phenylketonuria (PKU)
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 May 2007
FDA Approves Tindamax(R) for Bacterial Vaginosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 May 2007
Medtronic's Bryan(R) Cervical Disc System to Be Reviewed by FDA Panel
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 23 May 2007
SenoRx Announces 510(k) Clearance for Its Multi-Lumen Radiation Balloon
Devices Oncology FDA
 HSMN NewsFeed - 22 May 2007
FDA Approves Lybrel, First Low Dose Combination Oral Contraceptive Offering Women the Opportunity to Be Period-Free Over Time
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 May 2007
Acorda Therapeutics and FDA Reach Agreement on Special Protocol Assessment for Second Phase 3 Study of Fampridine-SR in Multiple Sclerosis
Biopharmaceuticals Neurology
 HSMN NewsFeed - 22 May 2007
Advancis Pharmaceutical Announces FDA Acceptance of Amoxicillin PULSYS NDA
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 21 May 2007
Actavis Launches Finasteride 5 mg Tablets in the U.S.
Biopharmaceuticals Generics Urology FDA
 HSMN NewsFeed - 21 May 2007
U.S. FDA Approves VELCADE(R) + DOXIL(R) Combination for Treatment of Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 21 May 2007
Luna Innovations Blood Circuit Monitor Receives FDA Clearance
Devices Surgery Cardiology FDA
 HSMN NewsFeed - 21 May 2007
Sandoz Receives FDA Approval for Generic Toprol XL(R) 50 mg Tablet
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 21 May 2007
FoxHollow Provides Update on Regulatory Process for Its NightHawk(TM) System
Devices Interventional FDA
 HSMN NewsFeed - 21 May 2007
Talabostat Clinical Program Put on Clinical Hold by FDA
Biopharmaceuticals Oncology
 HSMN NewsFeed - 20 May 2007
Teva Provides Update on Generic Lotrel(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 19 May 2007
FDA Issues Approvable Letter for SPD465 (Triple-Bead Mixed Amphetamine Salts) for the Treatment of ADHD in Adults
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 May 2007
New Drug Application Submitted For Novel Investigational Antibiotic Ceftobiprole
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 May 2007
KV Pharmaceutical Company Announces Approval for Two Strengths of Generic Versions of Toprol-XL(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 18 May 2007
American Medical Systems Announces the Introduction of the TherMatrx TMX3000(TM) Office Thermo Therapy System
Devices Urology FDA
 HSMN NewsFeed - 18 May 2007
FDA Approves Astrazeneca's Once-Daily Seroquel XR(TM) Extended-Release Tablets for the Treatment of Schizophrenia
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 May 2007
FDA Approves Lovenox(R) (Enoxaparin Sodium Injection) for the Most Severe Type of Heart Attack
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 17 May 2007
FDA Advisory Committee Unanimously Votes in Favor of Acambis' Smallpox Vaccine
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 May 2007
Ranbaxy Receives Tentative FDA Approval for Fexofenadine Hydrochloride Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 17 May 2007
Ascent Healthcare Receives 510(k) Clearance on Alcon MACKOOL Phaco Tips
Devices Ophthalmology FDA
 HSMN NewsFeed - 17 May 2007
DUSA Pharmaceuticals Receives Orphan Drug Designation for Levulan(R) PDT to Treat Esophageal Dysplasia
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 May 2007
Cell Therapeutics, Inc. Receives FDA Special Protocol Assessment (SPA) Comments on the Design of Phase III Trial of Pixantrone in Relapsed Indolent NHL
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 17 May 2007
Given Imaging Receives U.S. Marketing Clearance for PillCam(R) SB 2 and RAPID(R) 5 Software
Devices Gastroenterology FDA
 HSMN NewsFeed - 16 May 2007
FDA Advisory Committee Recommends Expanded Use of FluMist(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 May 2007
Berlin Heart's EXCOR(R) Pediatric Receives Conditional Investigational Device Exemption (IDE) Approval
Devices FDA Cardiology
 HSMN NewsFeed - 16 May 2007
Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 May 2007
Lupin Receives US FDA Approval for Simvastatin Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 15 May 2007
Hamilton Thorne Biosciences Announces Third-round FDA Marketing Clearance of its ZILOS-tk(R) Zona Laser Drill for Additional Clinical Applications of Blastomere Biopsy and Trophectoderm Biopsy
Devices FDA
 HSMN NewsFeed - 15 May 2007
ArthroCare Receives FDA Clearance to Treat Malignant Lesions in the Spine
Devices FDA Orthopaedic Neurosurgery
 HSMN NewsFeed - 15 May 2007
OMRIX Biopharmaceuticals Receives Food and Drug Administration (FDA) Approval for Liquid Fibrin Sealant, Evicel(TM), For Use in Vascular Surgery
Devices FDA
 HSMN NewsFeed - 15 May 2007
Spectrum Pharmaceuticals Announces FDA'S Oncology Drug Advisory Committee to Review Satraplatin for the Treatment of Hormone Refractory Prostate Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 14 May 2007
HealthTronics Announces FDA Clearance and Launch of the New LithoDiamond ULTRA Lithotripter
Devices Urology FDA
 HSMN NewsFeed - 14 May 2007
CV Therapeutics Submits New Drug Application For Regadenoson
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 14 May 2007
Questcor Receives FDA Action Letter for H.P. Acthar(R) Gel for Treatment of Infantile Spasms
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 11 May 2007
FDA Approves Dey, L.P.'s Perforomist(TM) (Formoterol Fumarate) Inhalation Solution for Maintenance Treatment of COPD
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 May 2007
Barr Receives Tentative Approval for a Generic Version of Razadyne(R) Tablets, 4mg, 8mg and 12mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 May 2007
Abraxis BioScience Receives FDA Approvals for Clindamycin Injection, USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 May 2007
Teva Announces Approval and Shipment of Generic Omnicef(R) Capsules and POS
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 May 2007
FDA Approves SCHWARZ PHARMA's Neupro(R) (Rotigotine Transdermal System) for the Treatment of Early-Stage Parkinson's Disease in USA
Biopharmaceuticals Drug Delivery Neurology FDA
 HSMN NewsFeed - 9 May 2007
FDA Advisory Panel Reviews DOR BioPharma's orBec(R) for Treatment of GI GVHD
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 May 2007
Acorn Cardiovascular to Conduct 50-Patient Confirmatory Trial for FDA Approval of CorCap(TM) Cardiac Support Device
Devices FDA Cardiology
 HSMN NewsFeed - 9 May 2007
LeMaitre Vascular Receives IDE Approval to Begin the 'Unite' UniFit Abdominal Stent Graft Pivotal Study
Devices FDA
 HSMN NewsFeed - 9 May 2007
FDA Advisory Committee Reviews Data on IDM Pharma's Junovan(TM) (mifamurtide) for Treatment of Osteosarcoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 9 May 2007
New Device Granted Humanitarian Exemption to Treat Intracranial Aneurysms
Devices FDA Neurology Interventional
 HSMN NewsFeed - 9 May 2007
IMPAX Receives Final FDA Approval for Generic Ditropan(R) XL 5 mg and 10 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 9 May 2007
The Wisconsin Heart Hospital First in U.S. to Use Newly FDA-Cleared Device to Perform Blood Vessel Graft During Bypass Surgery
Devices Surgery Cardiology
 HSMN NewsFeed - 9 May 2007
St. Jude Medical Announces FDA Approvals of Current ICD and Promote CRT-D Heart Failure Devices
Devices Cardiology FDA
 HSMN NewsFeed - 9 May 2007
Generic Medical Devices Receives FDA 510(k) Clearance for Universal Surgical Mesh
Devices Surgery FDA
 HSMN NewsFeed - 9 May 2007
St. Jude Medical Announces FDA Approval of the OptiSense(TM) Pacing Lead
Devices Cardiology FDA
 HSMN NewsFeed - 9 May 2007
Dendreon Receives Complete Response Letter From FDA for Provenge(R) Biologics License Application
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 May 2007
St. Jude Medical Announces FDA Clearance and European Approvals for Cardiac Mapping and Navigation Software
Devices Cardiology FDA Regulatory
 HSMN NewsFeed - 8 May 2007
Lupin Announces Final FDA Approval of Cefdinir for Oral Suspension, 250 mg/5 mL, Launches Entire Product Family
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 8 May 2007
Teva Announces Tentative Approval of Generic Gemzar(R) for Injection
Biopharmaceuticals Generics Oncology FDA
 HSMN NewsFeed - 8 May 2007
Sanguine Continues Work Toward FDA 510(k) Application
Devices FDA
 HSMN NewsFeed - 7 May 2007
FDA Approves Aastrom Phase III IND for Treatment of Osteonecrosis of the Femoral Head
Regenerative Medicine Orthopaedic
 HSMN NewsFeed - 7 May 2007
Barnev Inc., Developer of FDA-Cleared Computerized Labor Monitoring System Appoints James F. Puffenberger President, Announces Opening of North American Headquarters
Devices Monitoring Personnel
 HSMN NewsFeed - 7 May 2007
Reliant Technologies Receives FDA Clearance for Fraxel re:fine(TM) Laser System
Devices Dermatology FDA
 HSMN NewsFeed - 7 May 2007
Abbott Seeks U.S. and E.U. Regulatory Approvals for HUMIRA(R) (Adalimumab) as a Treatment for Juvenile Rheumatoid Arthritis
Biopharmaceuticals FDA Regulatory
 HSMN NewsFeed - 7 May 2007
Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 May 2007
Thoratec Receives FDA Approval of Continued Access Protocol for Bridge ARM of Its HeartMate II(R) Pivotal Trial
Devices Cardiology FDA
 HSMN NewsFeed - 3 May 2007
Cipher Pharmaceuticals receives approvable letter from FDA for CIP-TRAMADOL ER
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 May 2007
Indevus Announces FDA Approval of SUPPRELIN(R)-LA
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 May 2007
Diazyme Receives FDA 510(k) Clearance for Low Cost Enzymatic Assay
Diagnostics FDA
 HSMN NewsFeed - 3 May 2007
Barrier Therapeutics Receives FDA Approval for Solagé(R) Topical Solution Labeling Expansion
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 3 May 2007
Luna Innovations Submits FDA 510(k) Application for EDAC(TM) QUANTIFIER Monitor
Devices Monitoring Cardiology Surgery FDA
 HSMN NewsFeed - 3 May 2007
Avantis Medical Systems Announces FDA 510(k) Approval for the Third Eye Retroscope
Devices Gastroenterology FDA
 HSMN NewsFeed - 3 May 2007
Hansen Medical Receives FDA Clearance for Commercialization of Its First Generation Robotic Platform for Catheter Mapping Procedures
Devices Cardiology FDA
 HSMN NewsFeed - 3 May 2007
St. Jude Medical Announces U.S. And European Approvals of Zephyr Pacemaker Family of Devices
Devices Cardiology FDA Regulatory
 HSMN NewsFeed - 3 May 2007
Mylan Announces Tentative FDA Approval for Letrozole Tablets, USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 2 May 2007
MINRAD International, Inc. Announces FDA Approval of Sojourn(TM) Sevoflurane
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 May 2007
Barr Receives Approval for Generic Nimotop(R) Capsules, 30 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 2 May 2007
FDA Approves FRAGMIN(R) as First Low-Molecular-Weight Heparin for Extended Treatment to Reduce the Recurrence of Blood Clots in Patients with Cancer
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 May 2007
FDA Clearance Received for Heart Attack Stem Cell Clinical Trial
Regenerative Medicine Cardiology FDA
 HSMN NewsFeed - 2 May 2007
FDA Approves Oscient Pharmaceuticals' FACTIVE(R) Tablets for Five-Day Treatment of Community-Acquired Pneumonia
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 May 2007
FDA Advisory Committee Finds Substantial Evidence to Support Advair 500/50 in Reducing COPD Exacerbations
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 May 2007
CleveMed Receives FDA Clearance to Market Wireless Movement Disorder Monitor
Devices Neurology Monitoring
 HSMN NewsFeed - 1 May 2007
Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 30 Apr 2007
Enzon Receives FDA Clearance of Its Recently Filed PEG-SN38 IND Application
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Apr 2007
Humate-P(R) Approved to Prevent Excessive Bleeding in Patients with von Willebrand Disease Undergoing Surgery
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Apr 2007
Duramed's ENJUVIA(TM) (Synthetic Conjugated Estrogens, B) Tablets Receives Two New FDA Approvals
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Apr 2007
FDA Approves Lantus SoloStar(R) - A New Prefilled Disposable Insulin Pen For Use With LANTUS(R) In People With Type 1 And Type 2 Diabetes
Biopharmaceuticals Endocrinology Drug Delivery FDA
 HSMN NewsFeed - 30 Apr 2007
Alma Lasers(TM) Receives FDA Clearance for the Accent(TM) Dual Mode RF System
Devices FDA
 HSMN NewsFeed - 30 Apr 2007
InSite Vision Announces FDA Approval for AzaSite(TM) Approval Triggers $19 Million Milestone Payment
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 30 Apr 2007
Aastrom Initiates Adult Stem Cell Clinical Trial for Peripheral Arterial Disease
Regenerative Medicine FDA
 HSMN NewsFeed - 30 Apr 2007
FDA Approves Once-Daily Veramyst(TM) (fluticasone furoate) Nasal Spray for Treatment of Seasonal and Year-Round Allergy Symptoms in Adults and Children as Young as Two Years
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Apr 2007
FDA Approves Once-Daily Veramyst(TM) (fluticasone furoate) Nasal Spray for Treatment of Seasonal and Year-Round Allergy Symptoms in Adults and Children as Young as Two Years
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Apr 2007
Inspire Announces FDA Approval Of AzaSite(TM)
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 27 Apr 2007
FDA Approves INVEGA (TM) for Long-Term Maintenance Treatment of Schizophrenia
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Apr 2007
Merck Receives Non Approvable Letter from FDA for ARCOXIA(R) (etoricoxib)
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Apr 2007
Cipher Pharmaceuticals receives approvable letter from FDA for CIP-ISOTRETINOIN
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 26 Apr 2007
ArthroCare Receives FDA Clearance to Market Magnum(R) PI Knotless Implant System
Devices Orthopaedic FDA
 HSMN NewsFeed - 26 Apr 2007
Ranbaxy Receives Final Approval to Manufacture and Market Zolpidem Tablets for Insomnia
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 26 Apr 2007
Novagali Pharma Announces FDA Clearance of IND for US Pivotal Phase III Trial of Nova22007 for Treatment of Dry Eye Syndrome
Biopharmaceuticals Ophthalmology
 HSMN NewsFeed - 25 Apr 2007
Ranbaxy Receives Approval to Manufacture and Market Pravastatin Sodium Tablets in U.S.
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 25 Apr 2007
New Indication for SINGULAIR(R) (montelukast sodium) Approved to Prevent Exercise-induced Bronchoconstriction
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Apr 2007
BD Announces FDA 510(k) Submission of Two Hour Test to Identify Superbug in Patients with Positive Blood Cultures
Diagnostics FDA
 HSMN NewsFeed - 25 Apr 2007
Dr. Reddy's Announces the Launch of Zolpidem Tartrate Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 24 Apr 2007
FDA Advisory Committee Recommends Accelerated Approval of Pfizer's Maraviroc for Treatment-Experienced Patients Infected with CCR5-tropic HIV-1
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 24 Apr 2007
Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Apr 2007
RSB Spine Announces Another 510(k) Approval for the InterPlate(TM) Vertebral Body Replacement Implant System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 24 Apr 2007
Innocoll Announces Outcome of FDA Meeting to Commence Phase 3 Development of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections
Devices Surgery FDA
 HSMN NewsFeed - 24 Apr 2007
Direct Medical Systems Received FDA Clearance to Market Their InnovaSound USB Ultrasound Systems, Effective 18 April 2007
Devices FDA
 HSMN NewsFeed - 23 Apr 2007
Edwards Lifesciences' Response to Warning Letter Adequately Addresses FDA's Concerns
Devices FDA
 HSMN NewsFeed - 23 Apr 2007
Caraco Pharmaceutical Laboratories Ltd. Announces FDA Approval to Market Generic Ambien(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 23 Apr 2007
Mylan Announces Final FDA Approval and Immediate Shipment of Zolpidem Tartrate Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 23 Apr 2007
NMT Medical Receives FDA Approval for Modifications in Pivotal U.S. PFO/Stroke Trial
Devices FDA Interventional Cardiology Neurology
 HSMN NewsFeed - 23 Apr 2007
Pharmacyclics Announces FDA Filing of New Drug Application for Xcytrin(R) Injection to Treat Lung Cancer Brain Metastases
Biopharmaceuticals Oncology
 HSMN NewsFeed - 23 Apr 2007
Ellex Gains US FDA Approval for 30XL Laser Slit Lamp
Devices FDA Ophthalmology
 HSMN NewsFeed - 20 Apr 2007
Abbott Submits New Drug Application for Combination Niaspan(R)/Simvastatin Tablet
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Apr 2007
FDA Grants Full Approval for DepoCyt(R) for the Treatment of Lymphomatous Meningitis
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 19 Apr 2007
Abraxis BioScience Receives FDA Tentative Approval for Fosphenytoin Sodium Injection, USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 19 Apr 2007
FDA Grants IDE Approval to TransMedics for the Pilot Phase of the PROCEED Clinical Trial for Its Organ Care System(TM) - the First System to Support Beating Heart Transplant
Devices FDA
 HSMN NewsFeed - 18 Apr 2007
FDA Confirms Mylan's Status as the Only Approved ANDA for all Strengths of Amlodipine Besylate Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 18 Apr 2007
St. Jude Medical Announces FDA Approval of Internet-Based Data Management System For Implantable Cardiac Devices
Devices Cardiology FDA
 HSMN NewsFeed - 18 Apr 2007
Cytomedix Provides Update On FDA Review
Devices Wound Care FDA
 HSMN NewsFeed - 18 Apr 2007
Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Apr 2007
Cepheid's Xpert(TM) MRSA Test for Methicillin-Resistant Staphylococcus Aureus Receives FDA Clearance
Diagnostics FDA
 HSMN NewsFeed - 17 Apr 2007
FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations
Devices Cardiology FDA Product Recall
 HSMN NewsFeed - 17 Apr 2007
FDA Licenses First U.S. Vaccine for Humans Against Avian Influenza
Biopharmaceuticals Licensing
 HSMN NewsFeed - 17 Apr 2007
Merck Submits New Cross-Protection Data for GARDASIL(R) to the FDA and Seeks New Indications for Vaginal and Vulvar Cancers
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 17 Apr 2007
Boston Scientific Announces FDA Approval of Innovative Heart Failure Lead
Devices Cardiology FDA
 HSMN NewsFeed - 17 Apr 2007
WaveLight Receives Wavefront-Guided and Mixed Astigmatism Approval for ALLEGRETTO WAVE(R) Eye-Q
Devices Ophthalmology FDA
 HSMN NewsFeed - 17 Apr 2007
Hi-Tech Pharmacal Receives Tentative Approval for Ciclopirox Topical Solution
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 17 Apr 2007
Nanogen Submits 510(K) for Cystic Fibrosis Genetic Assay and NanoChip(R) 400 System
Diagnostics FDA
 HSMN NewsFeed - 17 Apr 2007
Reclast(R) Receives US Approval as a Highly Effective Treatment for Patients with Paget's Disease of the Bone
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Apr 2007
Spine Wave Receives FDA Clearance for CapSure(TM) PS Pedicle Screw System
Devices FDA Orthopaedic Neurosurgery
 HSMN NewsFeed - 16 Apr 2007
FDA Approves Fast Track Designation for Naryx Pharma's Product for Chronic Sinusitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Apr 2007
E-Z-EM Receives FDA 510(k) Clearance for EmpowerMR Injector System
Devices Radiology FDA
 HSMN NewsFeed - 16 Apr 2007
Abbott Announces FDA Clearance and Launch of New FreeStyle Lite(TM) Blood Glucose Monitoring System
Devices Monitoring Endocrinology FDA
 HSMN NewsFeed - 16 Apr 2007
FDA Accepts Satraplatin NDA And Grants Priority Review
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Apr 2007
Boston Scientific Resolves CRM Warning Letter Deficiencies
Devices Cardiology FDA
 HSMN NewsFeed - 16 Apr 2007
Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 16 Apr 2007
ev3's Onyx HD 500 Receives HDE Approval from FDA for Treatment of Cerebral Aneurysms
Devices Interventional Neurology FDA
 HSMN NewsFeed - 16 Apr 2007
Spine Wave Receives FDA Clearance for the StaXx(R) FX Structural Kyphoplasty System
Devices FDA Neurosurgery Orthopaedic
 HSMN NewsFeed - 16 Apr 2007
FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status
Biopharmaceuticals Oncology
 HSMN NewsFeed - 13 Apr 2007
Mylan Announces Final FDA Approval for Glipizide and Metformin Hydrochloride Tablets
Biopharmaceuticals Generics Endocrinology FDA
 HSMN NewsFeed - 13 Apr 2007
FDA Approves New Dose of RISPERDAL(R) CONSTA(R) for Schizophrenia Treatment
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Apr 2007
GSK Announces FDA Approval of Altabax(TM) (Retapamulin Ointment), 1%
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Apr 2007
FDA Advisory Committee Recommends Against Approval for Merck's NDA for ARCOXIA(R) (etoricoxib)
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Apr 2007
Lupin Receives US FDA Approval for Novel Formulation of Suprax(R) Suspension
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Apr 2007
Ranbaxy Receives FDA Approval To Market Loratadine Antihistamine Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 11 Apr 2007
FDA Requires No Further Response on Warning Letter
Devices Oncology FDA
 HSMN NewsFeed - 11 Apr 2007
Pro-Pharmaceuticals Receives Letter from the FDA for New Drug Application for DAVANAT(R)/ 5-FU
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Apr 2007
Cell Therapeutics, Inc. (CTI) Announces XYOTAX(TM) Has Fast Track Designation for Women With Advanced Lung Cancer Who Are Performance Status 2 (PS2)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Apr 2007
Neurochem's eprodisate (KIACTA(TM)) PDUFA date extended three months by FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Apr 2007
Boca Pharmacal Receives FDA Approval for Generic Version of Panlor(R)SS
Biopharmaceuticals Generics FDA Distribution
 HSMN NewsFeed - 10 Apr 2007
Cipher Pharmaceuticals comments on Ortho-McNeil Citizen Petition
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 9 Apr 2007
CryoCor PMA To Be Reviewed at FDA Panel
Devices Cardiology FDA
 HSMN NewsFeed - 9 Apr 2007
FDA approves Cangene's HepaGam B(TM) for a second indication; for use in hepatitis B-positive liver transplant recipients
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Apr 2007
Tepha, Inc. Receives FDA Clearance for First Medical Device Derived from New Class of Biopolymers
Devices Surgery FDA
 HSMN NewsFeed - 9 Apr 2007
Atrium Medical Receives FDA Approval for its Novel C-QURLite(TM) Mesh
Devices Surgery FDA
 HSMN NewsFeed - 6 Apr 2007
Wyeth Provides Update on FDA Review of the Torisel New Drug Application
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Apr 2007
Abbott Announces FDA Approval of a New Coated Niaspan Tablet
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Apr 2007
FDA approves Cangene's HepaGam B(TM) for a second indication; for use in hepatitis B-positive liver transplant recipients
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Apr 2007
Barr Confirms Patent Challenge of Ambien CR(R)
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 5 Apr 2007
MIV Therapeutics Announces Pivotal Test Results Further Validating Company Stent Coatings Meet Critical FDA Fatigue Guidelines
Devices Interventional Cardiology
 HSMN NewsFeed - 5 Apr 2007
PuriCore Receives FDA 510(k) Approval for Endoscope Disinfectant System in US
Devices FDA
 HSMN NewsFeed - 4 Apr 2007
Possis Receives New FDA Approval for Spiroflex(R) VG Catheter
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 4 Apr 2007
Genta Appeals FDA Decision on Genasense(R) in CLL
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Apr 2007
Pharmacyclics' Xcytrin New Drug Application for Treatment of Lung Cancer Brain Metastases to Be Filed Over Protest
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Apr 2007
Innocoll Receives FDA Approval to Commence Phase 2 Clinical Development with its CollaRx(R) BUPIVACAINE IMPLANT for the Management of Post-operative Pain
Devices Surgery
 HSMN NewsFeed - 3 Apr 2007
Stereotaxis Announces FDA Approval of Partnered 8mm Ablation Catheter
Devices Cardiology FDA
 HSMN NewsFeed - 3 Apr 2007
FDA Grants Fast Track Designation to Alzheimer's Disease Drug Candidate AZD-103/ELND005
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 3 Apr 2007
Cardica Receives 510(k) Clearance for C-Port Flex A System for Use in Coronary Artery Bypass Surgery
Devices Cardiology Surgery FDA
 HSMN NewsFeed - 3 Apr 2007
IMPAX Announces FDA Approval of Generic Corzide
Biopharmaceuticals FDA Generics
 HSMN NewsFeed - 2 Apr 2007
Draeger Medical Introduces New WiFi-Based Infinity(R) TeleSmart Patient-Worn Telemetry System
Devices Monitoring FDA
 HSMN NewsFeed - 2 Apr 2007
FDA Approves Accelerated Dosing Schedule for GlaxoSmithKline's Twinrix(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Apr 2007
FDA Approves Rhophylac(R) for the Treatment of Immune Thrombocytopenic Purpura (ITP)
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Apr 2007
EndoGastric Solutions Receives FDA Clearance for First Transoral Surgical Product: StomaphyX(TM) Gets Clearance First
Devices Gastroenterology FDA
 HSMN NewsFeed - 2 Apr 2007
EPIX Provides Update Regarding Status of Vasovist(TM) Appeal
Biopharmaceuticals Radiology FDA
 HSMN NewsFeed - 2 Apr 2007
FoxHollow Announces FDA 510(k) Submission for the NightHawk(TM) System
Devices Interventional FDA
 HSMN NewsFeed - 2 Apr 2007
Abbott Seeks U.S. and E.U. Regulatory Approval for HUMIRA(R) (Adalimumab) in Psoriasis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 2 Apr 2007
FDA Approves JANUMET(TM) for Type 2 Diabetes, Offering Powerful Glucose Control of a DPP-4 Inhibitor and Metformin in a Single Tablet
Biopharmaceuticals FDA Endocrinology
 HSMN NewsFeed - 31 Mar 2007
Baxter Announces FDA Approval Of Ceprotin For Severe Congential Protein C Deficiency
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Mar 2007
Cephalon Provides Update Related to NUVIGIL(TM) New Drug Application
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Mar 2007
Novartis Suspends US Marketing and Sales of Zelnorm(R) in Response to Request from FDA
Biopharmaceuticals Gastroenterology FDA
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