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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 - 7 Nov 2007
Watson Files FDA Application for Generic YAZ(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 6 Nov 2007
Kingfisher Announces 510(k) Submission to FDA for Approval of KFH Energy
Devices FDA
 HSMN NewsFeed - 6 Nov 2007
U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Adolescent Patients With Schizophrenia
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Nov 2007
Momenta Pharmaceuticals Announces Receipt of FDA Letter -- M-Enoxaparin ANDA Not Approvable in Current Form
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 5 Nov 2007
Abbott Confirms FDA Advisory Panel to Review XIENCE(TM) V Drug Eluting Stent on November 29
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 5 Nov 2007
Collagen Matrix, Inc. Receives FDA 510(k) Clearance for SynOss(TM) Synthetic Mineral Bone Graft Material
Devices Orthopaedic FDA
 HSMN NewsFeed - 2 Nov 2007
Progen Update on Phase 3 Clinical Program for PI-88 in Liver Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Nov 2007
Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k) Clearance
Diagnostics FDA
 HSMN NewsFeed - 1 Nov 2007
Pozen Announces Trexima(TM) (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Nov 2007
Redsense Medical Receives FDA Approval for Blood Loss Detection Device
Devices FDA
 HSMN NewsFeed - 1 Nov 2007
AVI BioPharma Receives Orphan Drug Designation for AVI-4658 for Treatment of Duchenne Muscular Dystrophy
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Nov 2007
Perrigo Announces that Dexcel's Settlement with AstraZeneca Allows OTC Omeprazole Launch Following Final FDA Approval
Biopharmaceuticals Generics Litigation
 HSMN NewsFeed - 1 Nov 2007
FDA Accepts New Drug Application for NEBIDO(R) Submitted by Indevus
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 31 Oct 2007
CVRx(R), Inc. Receives CE Mark Approval for Rheos(R) Baroreflex Hypertension Therapy(TM) System
Devices Cardiology FDA
 HSMN NewsFeed - 31 Oct 2007
Amedica Receives FDA 510(k) Clearance for Valeo(TM) Cervical Plate
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 31 Oct 2007
Allergan, Inc. Receives FDA Approval for COMBIGAN(TM) (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
Biopharmaceuticals Ophthalmology
 HSMN NewsFeed - 31 Oct 2007
StemCor Systems Receives FDA Clearance for Bone Marrow Harvesting System
Devices Regenerative Medicine FDA
 HSMN NewsFeed - 30 Oct 2007
Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
Devices
 HSMN NewsFeed - 30 Oct 2007
Barr Receives Tentative Approval for a Generic Version of Mirapex(R) Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 29 Oct 2007
Tasigna(R) receives US approval providing new hope to chronic myeloid leukemia patients with resistance or intolerance to existing therapies
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Oct 2007
Epicel(TM) Wins Marketing Approval for Severe Burn Victims
Devices Regenerative Medicine Wound Care FDA
 HSMN NewsFeed - 29 Oct 2007
Ranbaxy Receives Tentative Approval For Valsartan Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 29 Oct 2007
Johnson & Johnson Pharmaceutical Research & Development Submits New Drug Application for Paliperidone Palmitate
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Oct 2007
Jerini Submits New Drug Application for Icatibant in the Treatment of HAE to the FDA and Requests Priority Review
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Oct 2007
Adams Respiratory Therapeutics Receives Approvable Letter From FDA for Mucinex(R) With Codeine
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Oct 2007
Barr's Generic Version of Estrostep(R) Fe Tablets Approved
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 26 Oct 2007
Sorin Group: Announces U.S. FDA's Approval to Market Its Mitroflow Aortic Pericardial Heart Valve in the United States
Devices Cardiology FDA
 HSMN NewsFeed - 26 Oct 2007
ATS Medical Receives FDA Clearance for ATS Simulus Semi-Rigid Annuloplasty Ring
Devices Cardiology FDA
 HSMN NewsFeed - 25 Oct 2007
Spinal Elements, Inc. Receives FDA 510(k) Market Clearance for its Mosaic(TM) Spinal System as a Cervical Intervertebral Body Fusion Device (IBFD)
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 25 Oct 2007
QuantRx Biomedical Corporation Announces FDA 510(k) Clearance for Its Follicle Stimulating Hormone (FSH) Immunoassay Test
Diagnostics FDA
 HSMN NewsFeed - 25 Oct 2007
KV Pharmaceutical Announces FDA Approval for Morphine ER 100 mg and 200 mg Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 24 Oct 2007
AngioChem Announces IND Clearance From the US FDA for its Lead Product, ANG1005, for the Treatment of Brain Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Oct 2007
FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
Biopharmaceuticals
 HSMN NewsFeed - 24 Oct 2007
R7128 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Oct 2007
FDA Issues Approvable Letter for Stavzor(TM) Delayed Release Valproic Acid Capsules
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 23 Oct 2007
OmniVision Image Sensor Powers Avantis FDA-Cleared 'Third Eye(TM)' Disposable Endoscope Accessory for Colonoscopy
Devices Gastroenterology
 HSMN NewsFeed - 23 Oct 2007
Delcath Voluntarily Defers Accrual in Clinical Trials
Devices Drug Delivery FDA
 HSMN NewsFeed - 22 Oct 2007
Sequella Lead Drug Compound SQ109 Receives Orphan Drug Status From the US FDA and Orphan Medicinal Product Designation From the European Medicines Agency for the Treatment of Tuberculosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Oct 2007
FDA Approves Genzyme's Renvela(TM) for Dialysis Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Oct 2007
Renal Solutions, Inc. Announces FDA 510(k) Clearance of New Design of the Allient(R) Sorbent Hemodialysis System for Chronic and Acute Hemodialysis
Devices FDA
 HSMN NewsFeed - 22 Oct 2007
Voltaren(R) Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis
Biopharmaceuticals Pain Management FDA
 HSMN NewsFeed - 22 Oct 2007
Theravance Receives FDA Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Oct 2007
Sanofi Pasteur Receives FDA Approval of Meningococcal Vaccine for Children
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Oct 2007
DOR BioPharma Receives Not Approvable Letter From FDA for orBec(R) for Treatment of Gastrointestinal Graft-versus-Host Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Oct 2007
IMPAX Announces Tentative Approval of Generic Effexor XR(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 18 Oct 2007
FDA Clears bioMerieux's VIDAS(R) B.R.A.H.M.S PCT(R) Assay
Diagnostics FDA
 HSMN NewsFeed - 17 Oct 2007
FDA Approves Supplemental New Drug Applications for JANUVIA(TM) (sitagliptin)
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 17 Oct 2007
SenoRx Announces 510(k) Clearance for Its Breast Biopsy Ultrasound System
Devices Oncology FDA
 HSMN NewsFeed - 16 Oct 2007
FDA Advisory Committee Votes in Favor of Earlier Use of Phosphate Binders in Stage 4 Kidney Disease Patients With Hyperphosphatemia
Biopharmaceuticals
 HSMN NewsFeed - 16 Oct 2007
Genzyme Statement Regarding Results of FDA Advisory Committee Meeting on the Use of Phosphate Binders in Chronic Kidney Disease
Biopharmaceuticals
 HSMN NewsFeed - 16 Oct 2007
FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Oct 2007
CMS Receives FDA 510(k) Clearance for Monaco(TM), The Next Generation in IMRT Planning
Devices Oncology FDA
 HSMN NewsFeed - 16 Oct 2007
IST Receives FDA Clearance of Paramount(TM) IBF System for Minimally Invasive Spine Surgery
Devices Orthopaedic FDA
 HSMN NewsFeed - 16 Oct 2007
Ingen Announces New Medical Technology, OxyAlert(TM)
Devices FDA
 HSMN NewsFeed - 15 Oct 2007
Hand-Held Fluid Aspiration Device FDA Cleared: New PowrSyringe Platform Added to Pinyons Medical Technology
Devices FDA
 HSMN NewsFeed - 15 Oct 2007
Knopp Neurosciences Receives Orphan Designation for KNS-760704 for Treatment of ALS
Biopharmaceuticals FDA Neurology
 HSMN NewsFeed - 15 Oct 2007
Labopharm appeals FDA's decision on once-daily tramadol
Biopharmaceuticals Pain Management FDA
 HSMN NewsFeed - 15 Oct 2007
Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on NMED-1077
Biopharmaceuticals Pain Mangement FDA
 HSMN NewsFeed - 15 Oct 2007
FDA Expands VELCADE(R) (Bortezomib) for Injection Label for Patients with Multiple Myeloma
Biopharmaceuticals FDA Oncology
 HSMN NewsFeed - 15 Oct 2007
FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections
Biopharmaceuticals Urology FDA
 HSMN NewsFeed - 15 Oct 2007
Abraxis Bioscience Reaches Agreement with the FDA Following Special Protocol Assessment for Phase III Trial of ABRAXANE in Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 Oct 2007
UPDATE: FDA Approves ISENTRESS(TM) (raltegravir) Tablets, First-in-Class Oral HIV-1 Integrase Inhibitor
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 15 Oct 2007
INNOVIVE Pharmaceuticals Announces Receipt of FDA Orphan Drug Designation for Tamibarotene for the Treatment of Acute Promyelocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 Oct 2007
FDA Removes Partial Hold on TELCYTA Clinical Development
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 Oct 2007
China Medical Technologies Announces Receipt of Korean FDA Approval for its HIFU System
Devices Oncology Regulatory
 HSMN NewsFeed - 15 Oct 2007
POZEN Submits Response to Approvable Letter for Trexima(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Oct 2007
AMDL Submits Data to FDA for Clearance to Market Its DR-70(R) Diagnostic Test to Monitor Colorectal Cancer Patients
Diagnostics Oncology
 HSMN NewsFeed - 15 Oct 2007
Elan and Biogen Idec Announce That FDA Will Extend Regulatory Review Period for TYSABRI(R) for Crohn's Disease
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 12 Oct 2007
Anesiva Outlines Comprehensive Commercialization Plan for FDA Approved Product Zingo(TM)
Biopharmaceuticals Drug Delivery Pain Management
 HSMN NewsFeed - 11 Oct 2007
Abiomed Announces Update on Impella(R) 2.5 510(k) Process
Devices Cardiology FDA
 HSMN NewsFeed - 10 Oct 2007
FDA Advisory Committee Recommends Medtronic's Endeavor(R) Drug-Eluting Stent for Approval
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 10 Oct 2007
FDA Clears Hand-Held Disposable Injector for Angiographic Imaging
Devices FDA
 HSMN NewsFeed - 10 Oct 2007
Lannett Company Comments on Recent FDA Announcement for Levothyroxine Sodium
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 Oct 2007
Anesiva Defines Regulatory Pathway for Adlea with FDA
Biopharmaceuticals Surgery
 HSMN NewsFeed - 9 Oct 2007
Angiotech announces intent to file 510(k) for its innovative 5-FU Central Venous Catheter (CVC) based on positive results from pivotal trial
Devices FDA
 HSMN NewsFeed - 9 Oct 2007
ThermoGenesis Announces 510(k) Clearance for AutoXpress(TM) Cord Blood Processing System
Devices Regenerative Medicine FDA
 HSMN NewsFeed - 9 Oct 2007
FDA Clears Biospace med's Revolutionary Low Dose Xray Imager
Devices Radiology Orthopaedic FDA
 HSMN NewsFeed - 9 Oct 2007
Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use for HemosIL(R) D-Dimer HS Assay
Diagnostics FDA
 HSMN NewsFeed - 8 Oct 2007
Dade Behring Receives FDA Clearance for Rapid-Result Gram Positive Microbiology Tests
Diagnostics FDA
 HSMN NewsFeed - 8 Oct 2007
OmniGuide Announces Launch of LightPath(TM) CO2 Laser Fiber
Devices FDA
 HSMN NewsFeed - 8 Oct 2007
FDA Clears OmniWave(TM) Endovascular System for Clot Removal in Peripheral Blood Vessels
Devices Interventional FDA
 HSMN NewsFeed - 8 Oct 2007
Teva Announces Approval of Generic Actonel(R)
Biopharmaceuticals FDA Generics
 HSMN NewsFeed - 8 Oct 2007
Ascent Healthcare Receives 510(k) Clearances to Reprocess Coronary Bypass Devices from Guidant and Medtronic
Devices Cardiology Surgery FDA
 HSMN NewsFeed - 8 Oct 2007
AVANIR Granted Special Protocol Assessment (SPA) From FDA for Confirmatory Phase III Trial of Zenvia in Patients With PBA
Biopharmaceuticals Neurology
 HSMN NewsFeed - 5 Oct 2007
Caraco Pharmaceutical Laboratories Ltd. Announces Tentative FDA Approval for Generic Zyrtec Chewable(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 5 Oct 2007
Power Medical Interventions, Inc. Receives 510(k) FDA Marketing Clearance
Devices Surgery FDA
 HSMN NewsFeed - 5 Oct 2007
Medtronic to Present Findings from the Comprehensive ENDEAVOR Clinical Experience to FDA Advisory Panel
Devices Interventional Cardiology
 HSMN NewsFeed - 5 Oct 2007
Teva Announces Tentative Approval of Generic Valtrex(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 5 Oct 2007
APP Receives Tentative FDA Approval for Irinotecan Hydrochloride Injection, 20 mg/mL Packaged in 2 mL and 5 mL Single-Use Vials
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 4 Oct 2007
AFP Imaging Corporation Receives FDA Clearance to Market NewTom(TM) VG Cone Beam Computed Tomography Scanner
Devices FDA Radiology Dental
 HSMN NewsFeed - 4 Oct 2007
FzioMed's PMA Application for Oxiplex Gel Accepted for Filing by FDA
Biopharmaceuticals Neurosurgery Orthopaedic
 HSMN NewsFeed - 4 Oct 2007
ZymoGenetics and Merck Serono Receive FDA Special Protocol Assessment for Atacicept Pivotal Study in Lupus Nephritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Oct 2007
FDA Approves GORE HELEX Septal Occluder for Treatment of Atrial Septal Defect
Devices FDA Interventional Cardiology
 HSMN NewsFeed - 3 Oct 2007
Transoma Medical Receives FDA Marketing Clearance for Sleuth(TM) Implantable ECG Monitoring System
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 3 Oct 2007
Ventana Submits INFORM(TM) HER2 SISH DNA Probe Assay for FDA Approval
Diagnostics Oncology FDA
 HSMN NewsFeed - 3 Oct 2007
Watson Files Application for Generic FEMCON(R) Fe
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 2 Oct 2007
Survival Data in FDA Approval for ERBITUX(R) (Cetuximab) Supports use as a Single Agent in Patients with Advanced Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Oct 2007
Hitachi Medical Systems America Announces FDA Clearance of Its OASIS(TM) MR System
Devices Radiology FDA
 HSMN NewsFeed - 2 Oct 2007
Abbott Broadens Use of i-STAT Handheld Blood Analyzer with CLIA Waiver Granted by FDA for CHEM8+ Test Cartridge
Diagnostics FDA
 HSMN NewsFeed - 1 Oct 2007
Merlyn Medical Announces FDA Approval for FlexWarmer in a Joint Agreement with Elltec and Suzuken
Devices FDA
 HSMN NewsFeed - 1 Oct 2007
Taxotere(R) (docetaxel) Granted FDA Approval to Treat Locally Advanced Head and Neck Cancer Prior to Chemoradiotherapy and Surgery
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Oct 2007
Emphasys Medical Announces PMA Submission for Bronchial Valve Therapy
Devices FDA
 HSMN NewsFeed - 1 Oct 2007
FDA Approves SYMLIN Pen-Injector Devices Offering Convenience and Accuracy for SYMLIN Use
Devices Drug Delivery Endocrinology FDA
 HSMN NewsFeed - 1 Oct 2007
OBS Medical Announces FDA Clearance of New Patient Safety Technology
Devices Monitoring FDA
 HSMN NewsFeed - 28 Sep 2007
CSL Biotherapies announces FDA marketing approval of Afluria(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Sep 2007
FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
Devices Surgery FDA
 HSMN NewsFeed - 28 Sep 2007
CardioDynamics Receives FDA 510(k) Clearance for Innovative Clinical Parameters and Electronic Medical Record Compatibility
Devices Cardiology FDA
 HSMN NewsFeed - 28 Sep 2007
Santhera Announces Start of US Phase III Clinical Trial with SNT-MC17 in Friedreich's Ataxia and Provides Details on Study Design
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 27 Sep 2007
CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 27 Sep 2007
AZOR(TM) Receives FDA Approval for Treatment of High Blood Pressure
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Sep 2007
FDA Approves New 300mg Loading Dose Tablet for PLAVIX(R) (clopidogrel bisulfate)
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 27 Sep 2007
Vanda Pharmaceuticals Submits Iloperidone New Drug Application
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Sep 2007
MGI PHARMA Announces Submission of Aquavan(R) New Drug Application
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Sep 2007
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Methimazole Tablets USP, 5 mg and 10 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 26 Sep 2007
Rcadia's COR Analyzer Family of Products Receives Second FDA Clearance
Devices Cardiology FDA
 HSMN NewsFeed - 26 Sep 2007
Watson Receives FDA Approval for Generic Accuneb(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 25 Sep 2007
ReGen Biologics Receives NSE Letter from FDA, Proceeding with Next Steps to Gain U.S. Market Clearance
Devices Orthopaedic FDA
 HSMN NewsFeed - 25 Sep 2007
Instrumentation Laboratory Receives FDA Clearance for HemosIL RecombiPlasTin 2G Assay
Diagnostics FDA
 HSMN NewsFeed - 25 Sep 2007
Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
Devices FDA
 HSMN NewsFeed - 25 Sep 2007
SORIN GROUP: Announces U.S. FDA'S Authorization to Market Its Memo 3D(TM) Annuloplasty Ring in the United States
Devices Cardiology FDA
 HSMN NewsFeed - 24 Sep 2007
Alcon Receives FDA Decision on RETAANE(R) Suspension for Wet AMD
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 24 Sep 2007
New Device for Clearing Blocked Arteries in the Legs Receives FDA Clearance for Peripheral Use - Procedures Performed Across the US Within First 48 Hours
Devices Interventional FDA
 HSMN NewsFeed - 24 Sep 2007
ISTO Technologies Receives 510(k) Clearance for a Novel Bone Graft Substitute and Bone Graft Extender
Devices Orthopaedic FDA
 HSMN NewsFeed - 24 Sep 2007
Cook Medical Receives FDA Approval to Begin U.S. Phase I Clinical Trial for Cook Zenith(R) Dissection Endovascular System
Devices Interventional FDA
 HSMN NewsFeed - 24 Sep 2007
US FDA Fast Tracks PI-88 for the Treatment of Post Resection Liver Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 24 Sep 2007
FDA Accepts sNDA for Expanded Use of Angiomax(R) (bivalirudin)
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 24 Sep 2007
NexMed Files NDA for Proprietary Erectile Dysfunction Treatment
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 24 Sep 2007
Cell Therapeutics, Inc. (CTI) Receives SPA Approval from FDA and Launches Gender-Specific Phase III Trial for Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 21 Sep 2007
Small Bone Innovations Introduces the Artelon(R) STT Spacer to Increase Treatment Options for Thumb Arthritis
Devices Orthopaedic FDA
 HSMN NewsFeed - 21 Sep 2007
BIO Celebrates Senate Passage of PDUFA Reauthorization Package
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Sep 2007
Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Sep 2007
Pipex Pharmaceuticals Plans November NDA Filing for COPREXA Based on Pre-NDA Meetings With FDA
Biopharmaceuticals Neurology
 HSMN NewsFeed - 20 Sep 2007
Cytomedix Receives FDA Clearance for AutoloGel
Biopharmaceuticals Wound Care FDA
 HSMN NewsFeed - 20 Sep 2007
FDA Panel Recommends Approval of SyntheMed's REPEL-CV(R) Adhesion Barrier for Pediatric Patients
Devices Surgery FDA
 HSMN NewsFeed - 20 Sep 2007
RSB Spine, LLC Announces FDA Clearance of New InterPlate(TM) Indications
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 20 Sep 2007
NDO Receives FDA 510(K) Clearance for Plicator II(TM)
Devices Gastroenterology FDA
 HSMN NewsFeed - 20 Sep 2007
FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Sep 2007
FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 19 Sep 2007
PREOS(R) Granted U.S. Orphan Drug Status for Treatment of Hypoparathyroidism
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Sep 2007
Digital Healthcare Wins FDA Approval for Retasure
Devices Ophthalmology FDA
 HSMN NewsFeed - 19 Sep 2007
FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Sep 2007
Nanosphere Announces First FDA Cleared Genetic Test for Warfarin Sensitivity and Nanotechnology-based Molecular Diagnostics Platform
Diagnostics FDA
 HSMN NewsFeed - 18 Sep 2007
Varian Medical Systems Receives FDA 510(k) Clearance for High-Definition Collimator That Enables Ultra-Fine Intensity-Modulated Radiosurgery
Devices Oncology
 HSMN NewsFeed - 18 Sep 2007
FDA Accepts Samaritan's Cushing's SP-6300 IND and Clears Phase II Study
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Sep 2007
St. Jude Medical Announces FDA Approval of Company's First Radiofrequency Wireless ICD and CRT-D Heart Failure Devices
Devices Cardiology FDA
 HSMN NewsFeed - 18 Sep 2007
X-spine Announces FDA Clearance for New Spinal System
Devices FDA Neurosurgery Orthopaedic
 HSMN NewsFeed - 17 Sep 2007
Former FDA Official John Taylor III to Join BIO as Executive Vice President of Health
Biopharmaceuticals Personnel
 HSMN NewsFeed - 17 Sep 2007
Infinity and MedImmune Receive Orphan Drug Designation for IPI-504 for Treatment of Gastroinstestinal Stromal Tumors
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 17 Sep 2007
FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis
Biopharmaceuticals Urology FDA
 HSMN NewsFeed - 17 Sep 2007
FDA Approves SOMA(R) (carisoprodol) 250 mg
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Sep 2007
Integra NeuroSciences Launches DuraGen XS Dural Regeneration Matrix
Devices Neurosurgery 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
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