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

Healthcare News Roundup: 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 - 7 Dec 2006
Tornier Receives FDA Clearance for the Salto Talaris(TM) Anatomic Ankle Prosthesis
Devices Orthopaedic 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
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

HSMN NewsFeed - 6 Dec 2006
Georgetown University Hospital First to Implant Patient with GORE PROPATEN Vascular Graft in the U.S. since Its FDA Clearance
Devices

HSMN NewsFeed - 4 Dec 2006
King Pharmaceuticals Reports FDA Approval of New Skelaxin(R) Label
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Dec 2006
In Interests of Patient Safety, Pfizer Stops All Torcetrapib Clinical Trials; Company Has Notified FDA and is in the Process of Notifying All Clinical Investigators and Other Regulatory Authorities
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 29 Nov 2006
FDA Clears Possis AngioJet(R) System for Blood Clot Removal in Veins
Devices FDA Interventional

HSMN NewsFeed - 28 Nov 2006
Abraxis BioScience Receives FDA Approval for Ampicillin and Sulbactam for Injection, 15g, USP
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 28 Nov 2006
Vicor Technologies Initiates Clinical Sites for Pivotal Vital Trial; Enrolls First Two Patients; Targets FDA 510(k) Submission in 2008
Devices Monitoring Cardiology

HSMN NewsFeed - 28 Nov 2006
Uroplasty, Inc. and CL Medical Announce FDA Clearance of I-Stop(TM) TOMS Sling for Treatment of Male Stress Urinary Incontinence
Devices Urology FDA

HSMN NewsFeed - 28 Nov 2006
Life Spine Announces FDA Approval of Kinetic(R)
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 28 Nov 2006
Siemens Introduces First Web-Enabled CT; SOMATOM Definition CT Receives FDA Approval for First Six Dual Energy Applications
Devices Radiology FDA

HSMN NewsFeed - 28 Nov 2006
St. Jude Medical Announces FDA Approval of Optim Lead Insulation for Cardiac Rhythm Management Therapy
Devices Cardiology FDA

HSMN NewsFeed - 28 Nov 2006
Lux Biosciences Receives FDA Clearance for LX211 IND
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 28 Nov 2006
LDR Receives FDA 510(k) Clearance for LP Multiaxial Screw
Devices FDA Neurosurgery Orthopaedic

HSMN NewsFeed - 28 Nov 2006
CryoCath receives FDA approval to expand AF trial
Devices FDA Cardiology

HSMN NewsFeed - 27 Nov 2006
Otsuka Pharmaceutical Co., Ltd. Announces FDA Clearance for the RAPIRUN(R) H. pylori Antibody Detection Kit
Diagnostics FDA

HSMN NewsFeed - 27 Nov 2006
E-Z-EM Receives FDA Approval for CAN-CiA Injector Sychronization Device
Devices Radiology FDA

HSMN NewsFeed - 27 Nov 2006
Medicsight Announces FDA Market Clearance for ColonCAR Software
Devices Radiology Gastroenterology Oncology FDA

HSMN NewsFeed - 27 Nov 2006
FDA Accepts as "Complete Response" Oscient Pharmaceuticals' Submission Following FACTIVE Approvable Letter for Five-Day CAP
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Nov 2006
Toshiba Announces FDA Clearance for New Vantage Atlas MRI System
Devices Radiology FDA

HSMN NewsFeed - 27 Nov 2006
AngioDynamics Announces FDA Clearance for Irreversible Electroporation Technology
Devices Cardiology FDA

HSMN NewsFeed - 21 Nov 2006
US FDA Grants Immtech's Oral Drug Candidate Pafuramidine (DB289) Orphan Drug Status for Treatment of PCP
Biopharmaceuticals HIV/AIDS FDA

HSMN NewsFeed - 21 Nov 2006
FDA Accepts DOR BioPharma's NDA Filing for orBec(R)
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 21 Nov 2006
Repligen Receives Orphan Drug Designation from the FDA for RG1068 for MRI Imaging of the Pancreas
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Nov 2006
FDA Clearance Received for CozMore(R) Insulin Technology System Updates
Devices Drug Delivery Endocrinology FDA

HSMN NewsFeed - 17 Nov 2006
Mentor Receives FDA Approval to Sell Its MemoryGel(TM) Breast Implants; Announces Conference Call to Discuss Approval
Devices FDA

HSMN NewsFeed - 17 Nov 2006
Allergan Announces FDA Approval of INAMED(R) Silicone-Filled Breast Implants for Breast Augmentation, Reconstruction and Revision Surgery
Devices FDA

HSMN NewsFeed - 17 Nov 2006
FDA Approves Home Discharge For Patients
Devices Cardiology FDA

HSMN NewsFeed - 16 Nov 2006
FDA Approves Herceptin(R) for the Adjuvant Treatment of HER2-Positive Node-Positive Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Nov 2006
Mercury Computer Systems Receives FDA Approval for Visage PACS and Visage CS Solutions for Medical Image Management
Devices Radiology FDA

HSMN NewsFeed - 16 Nov 2006
Medtronic Submits Final PMA Modules to FDA for Approval of the Endeavor Drug-Eluting Coronary Stent System
Devices Interventional Cardiology

HSMN NewsFeed - 16 Nov 2006
EDDA Receives FDA Clearance for its IQQA(R)-Liver Software for Multiphase MDCT
Devices Radiology FDA

HSMN NewsFeed - 15 Nov 2006
Diagnosoft, Inc. Receives FDA Approval for Cardiac MRI Quantitative Regional Function Software Based on the HARP(R) Technology
Devices Radiology Cardiology FDA

HSMN NewsFeed - 15 Nov 2006
Synta Pharmaceuticals Announces FDA Fast Track Designation for STA-4783 in Metastatic Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 15 Nov 2006
FDA Clears GORE PROPATEN Vascular Graft
Devices FDA

HSMN NewsFeed - 14 Nov 2006
FDA Allows Resumption of Lupus Trials with Epratuzumab
Biopharmaceuticals

HSMN NewsFeed - 14 Nov 2006
Abbott's HUMIRA(R) (adalimumab) Receives FDA Approval for Inhibiting Structural Joint Damage and Improving Physical Function in Patients With Psoriatic Arthritis
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Nov 2006
North American Scientific Announces FDA Clearance of its ClearPath(TM) HDR Breast Brachytherapy System
Devices Oncology FDA

HSMN NewsFeed - 14 Nov 2006
Neoteric Technology Ltd. Receives U.S. FDA Marketing Clearance for Blood Management Products
Devices FDA

HSMN NewsFeed - 14 Nov 2006
FDA Grants Priority Review for Soliris(TM) (eculizumab) BLA for Treatment of Paroxysmal Nocturnal Hemoglobinuria
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Nov 2006
Lenstec Receives FDA Clearance to Begin Clinical Trial of Softec HD IOL
Devices FDA Ophthalmology

HSMN NewsFeed - 13 Nov 2006
ReGen Biologics Announces Results of FDA Appeal
Devices FDA Orthopaedic

HSMN NewsFeed - 10 Nov 2006
IMPAX Receives Final FDA Approval and First-to-File Status for Generic Version of Ditropan(R) XL 15 mg
Biopharmaceuticals FDA Generics

HSMN NewsFeed - 10 Nov 2006
FDA Approves MIRAPEX for the Treatment of Moderate-to-Severe Primary Restless Legs Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Nov 2006
Mylan Receives Final FDA Approval for Oxybutynin Chloride Extended-release Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 10 Nov 2006
NicOx receives FDA feedback that no cardiovascular outcomes study required for naproxcinod NDA
Biopharmaceuticals Regulatory

HSMN NewsFeed - 9 Nov 2006
FDA Panel Unanimously Recommends Approval of Third Indication for Medtronic's INFUSE Bone Graft
Devices Orthopaedic FDA

HSMN NewsFeed - 9 Nov 2006
Cynosure Receives FDA Clearance for Smartlipo(TM) System
Devices FDA

HSMN NewsFeed - 9 Nov 2006
BioSphere Medical Receives FDA Approval For QuadraSphere(TM) Microspheres
Devices Interventional FDA

HSMN NewsFeed - 9 Nov 2006
Kodak Submits Final Clinical Data to FDA for Approval of CR System for Mammography
Devices Radiology FDA

HSMN NewsFeed - 9 Nov 2006
POZEN Submits Full Response to FDA Approvable Letter For Trexima(TM)
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Nov 2006
Mylan Announces Final FDA Approval for Doxycycline Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 8 Nov 2006
Instrumentation Laboratory Receives FDA Clearance for Homocysteine Assay
Diagnostics FDA

HSMN NewsFeed - 7 Nov 2006
Monoclonal Antibody, MORAb-009, Receives FDA Orphan Drug Designation for the Indication of Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Nov 2006
St. Jude Medical Announces FDA Approval of New ICD Software for the Merlin(TM) Patient Care System
Devices Cardiology FDA

HSMN NewsFeed - 6 Nov 2006
Wedgewood Village Pharmacy Will Vigorously Defend Against FDA Allegations
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Nov 2006
New Low Profile Optional Vena Cava Filter Receives Conditional FDA Approval to Begin U.S. Clinical Trial
Devices FDA

HSMN NewsFeed - 6 Nov 2006
Elbit Medical Group Announces Receipt of a Special Protocol Assessment From the FDA to Gamida Cell's Stemex(R) Registration Study
Regenerative Medicine FDA

HSMN NewsFeed - 6 Nov 2006
FDA Issues Approvable Letter for Entereg(R) (alvimopan) for POI
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Nov 2006
Boston Scientific Announces FDA Approval of NexStent(R) Carotid Artery Stenting System
Devices Interventional FDA Mergers & Acquisitions

HSMN NewsFeed - 3 Nov 2006
Heidelberg Engineering Receives FDA Clearance for World's First Spectral Domain OCT and Laser Angiography Instrument
Devices Ophthalmology FDA

HSMN NewsFeed - 3 Nov 2006
IMPAX Receives FDA Approval for Generic Versions of Urecholine(R) Tablets
Biopharmaceuticals FDA Generics

HSMN NewsFeed - 3 Nov 2006
NovaDel Pharma Receives FDA Approval of NitroMist(TM)
Biopharmaceuticals Drug Delivery FDA Cardiology

HSMN NewsFeed - 2 Nov 2006
FlowCardia, Inc. Initiates PATRIOT Pivotal Study Enrollment and Announces Coronary FDA 510(k) Submission for CROSSER(TM) Catheter System
Devices Interventional FDA

HSMN NewsFeed - 31 Oct 2006
Uroplasty Receives FDA Approval Letter for Macroplastique
Devices Urology FDA

HSMN NewsFeed - 31 Oct 2006
AVANIR Receives FDA Approvable Letter for Zenvia for the Treatment of Involuntary Emotional Expression Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 31 Oct 2006
Cook Incorporated Receives FDA Approval for Breakthrough Endovascular Graft
Devices Interventional FDA

HSMN NewsFeed - 31 Oct 2006
Pluristem Expects to Submit Pre-IND Document to FDA by End of 2006
Regenerative Medicine

HSMN NewsFeed - 30 Oct 2006
Avantogen Oncology Inc. Announces FDA Acceptance Of Its IND For The Novel Cancer Drug Candidate, RP101
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Oct 2006
Alpharma Receives FDA Approval for KADIAN(R) 80mg Capsules
Biopharmaceuticals FDA

HSMN NewsFeed - 30 Oct 2006
Artes Medical Announces FDA Approval for ArteFill(R) as the First Non-Resorbable Injectable Wrinkle Filler to Correct Smile Lines
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 30 Oct 2006
Toshiba Receives FDA Approval for Injector Synchronization Option
Devices Radiology FDA

HSMN NewsFeed - 27 Oct 2006
Elite Holds Clinical Guidance Meeting with the FDA on Its Abuse Deterrent Pain Program
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Oct 2006
FDA Clears New Test to Diagnose Rheumatoid Arthritis in Early Stages
Diagnostics FDA

HSMN NewsFeed - 26 Oct 2006
Abbott's HUMIRA(R) (Adalimumab) Granted FDA Priority Review for the Treatment of Moderately to Severely Active Crohn's Disease
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 26 Oct 2006
IMPAX Receives FDA Approval for Generic Version of Colestid(R) Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 26 Oct 2006
IDM Pharma Submits New Drug Application to the FDA for Junovan(TM) (mifamurtide) in the Treatment of Osteosarcoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 26 Oct 2006
Human Genome Sciences Announces Positive Special Protocol Assessment From FDA for Phase 3 Clinical Trials of LymphoStat-B(TM) In Systemic Lupus Erythematosus
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Oct 2006
FDA Approves New Medical Device for Elderly, Disabled and Bedridden
Devices FDA

HSMN NewsFeed - 24 Oct 2006
FDA Approves New Formulation for NEXIUM
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 24 Oct 2006
BioLucent Receives FDA Clearance for SAVI, a New Breast Brachytherapy Device
Devices Oncology FDA

HSMN NewsFeed - 24 Oct 2006
PLC Systems Receives FDA Permission to Begin RenalGuard(TM) Investigational Study
Devices FDA

HSMN NewsFeed - 23 Oct 2006
FDA Approves Betaseron(R) for Use After the First Event Suggestive of Multiple Sclerosis
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 23 Oct 2006
Schering-Plough Announces FDA Approval of NOXAFIL(R) (Posaconazole) for Treatment of Oropharyngeal Candidiasis (OPC)
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Oct 2006
SkinMedica(R) Announces FDA Approval of Desonate(TM) (Desonide) Gel 0.05% With Patented Hydrogel Technology for Treatment of Atopic Dermatitis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 23 Oct 2006
Adeza Receives FDA Approvable Letter for Gestiva
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Oct 2006
FDA Approves New, Once-a-Day COREG CR(TM) for the Treatment of Three Key Cardiovascular Conditions
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 20 Oct 2006
FDA Approves AstraZeneca's SEROQUEL(R) For Bipolar Depression Treatment
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Oct 2006
FDA Approves REYATAZ(R) (atazanavir sulfate) 300 mg Single Capsule Formulation in Combination Therapy for Adults With HIV-1 Infection
Biopharmaceuticals HIV/AIDS FDA

HSMN NewsFeed - 20 Oct 2006
FDA Approves Prescription Zaditor(R) for Over-The-Counter Relief From Itchy Eyes
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 19 Oct 2006
FDA Expands REMICADE(R) Indication for Ulcerative Colitis: Biologic Maintains Long-Term Clinical Remission and Mucosal Healing
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 19 Oct 2006
InfraReDx Announces FDA Clearance of its Near Infrared Spectroscopic System for Examining Coronary Arteries
Devices Interventional Cardiology

HSMN NewsFeed - 19 Oct 2006
FDA Awards PTC Therapeutics Orphan Products Development Grant for the Development of PTC124 in Duchenne Muscular Dystrophy
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Oct 2006
FDA Approves Allegra(R) (fexofenadine hydrochloride) Oral Suspension for Treatment of Seasonal Allergy Symptoms and Chronic Idiopathic Urticaria
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Oct 2006
Gen-Probe Receives FDA Clearance to Run Standalone APTIMA(R) Tests for Chlamydia and Gonorrhea on the TIGRIS(R) System
Diagnostics FDA

HSMN NewsFeed - 18 Oct 2006
Taxotere(R) Receives U.S. FDA Approval for the Treatment of Patients With Head and Neck Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Oct 2006
FDA Approves Once-Daily JANUVIA(TM), the First and Only DPP-4 Inhibitor Available in the United States for Type 2 Diabetes
Biopharmaceuticals FDA Endocrinology

HSMN NewsFeed - 17 Oct 2006
RITA Medical Systems Announces FDA 510(k) Clearance of HABIB 4X Laparoscopic(TM) Device
Devices Surgery FDA

HSMN NewsFeed - 16 Oct 2006
KCI Announces New FDA Labeling Clearance for V.A.C.(R) Therapy(TM)
Devices FDA Wound Care

HSMN NewsFeed - 16 Oct 2006
Pegasus Biologics Enters Wound Care Market With FDA Clearance for DermADAPT(TM) Biomatrix
Devices Wound Care FDA

HSMN NewsFeed - 16 Oct 2006
Neurochem submits a complete response to FDA approvable letter for KIACTA(TM)
Biopharmaceuticals

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