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

Healthcare News Roundup: FDA

HSMN NewsFeed - 21 Jun 2006
Morphotek Announces Orphan Drug Status Granted for MORAb-003, A Monoclonal Antibody for the Treatment of Ovarian Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Jun 2006
First AdNectin Therapeutic, CT-322, Clears FDA IND Review to Start Clinical Trials
Biopharmaceuticals Oncology

HSMN NewsFeed - 2 Jun 2006
Bristol-Myers Squibb Issues Statement on Oncologic Drugs Advisory Committee Vote in Favor of Investigational Drug Dasatinib
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Jun 2006
Ranbaxy Receives Approval To Market Doxycycline Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 1 Jun 2006
BioMarin and Alliant Announce FDA Approval of Orapred ODT
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 1 Jun 2006
Cell Therapeutics, Inc. (CTI) and FDA Agree on NDA Filing Strategy for XYOTAX(TM)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Jun 2006
Isis Pharmaceuticals Receives Orphan Drug Status for ISIS 301012 for the Treatment of Homozygous Familial Hypercholesterolemia
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Jun 2006
Point Therapeutics Receives Fast Track Designation for Talabostat
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 May 2006
American Bio Medica Receives FDA Clearance of Its Rapid TOX(TM)
Diagnostics FDA

HSMN NewsFeed - 31 May 2006
FDA Clears Boston Scientific System for Removing Clots from Arteries
Devices Interventional FDA

HSMN NewsFeed - 31 May 2006
Cardiome Announces Refusal To File Decision By The FDA
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 31 May 2006
Adolor's Complete Response to Approvable Letter for Entereg(R) (Alvimopan) in POI Accepted for Review by FDA
Biopharmaceuticals Gastroenterology Surgery FDA

HSMN NewsFeed - 31 May 2006
Corautus Genetics Announces Filing of Response to FDA Clinical Hold
Biopharmaceuticals Devices Drug Delivery Cardiology FDA

HSMN NewsFeed - 31 May 2006
MedicalCV, Inc. Submits 510(k) Application to FDA for ATRILAZE(TM) Minimally Invasive System
Devices Surgery Cardiology FDA

HSMN NewsFeed - 31 May 2006
Regeneron Receives Fast-Track Designation for the IL-1 Trap in CIAS1-Associated Periodic Syndromes (CAPS)
Biopharmaceuticals FDA

HSMN NewsFeed - 30 May 2006
Par Pharmaceutical Receives Final Approval to Market Polyethylene Glycol 3350 for Oral Solution
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 30 May 2006
Chembio Receives FDA Approval for Its Rapid HIV Tests
Diagnostics HIV/AIDS FDA

HSMN NewsFeed - 30 May 2006
CollaGenex Pharmaceuticals Receives FDA Approval for Oracea(TM)
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 30 May 2006
Smith & Nephew Announces FDA Approval of Burn Indication for VERSAJET(TM) in the USA
Devices Wound Care FDA

HSMN NewsFeed - 30 May 2006
Novelos Therapeutics Finalizes SPA with FDA for Phase 3 Trial in Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 May 2006
Teva Announces Tentative Approval for Generic Cozaar(R) Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 26 May 2006
Lupin Announces Final FDA Approval of Cefdinir Capsules
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 26 May 2006
FDA Approves ZOSTAVAX(R), Merck's New Vaccine for Prevention of Shingles in Adults Age 60 and Older
Biopharmaceuticals FDA

HSMN NewsFeed - 26 May 2006
FDA Accepts Submission for NitroMist as Complete Response
Biopharmaceuticals FDA

HSMN NewsFeed - 26 May 2006
FDA Advisory Committee to Consider Navy's Proposed 'RESUS' Trauma Trial at July 2006 Meeting
Biopharmaceuticals FDA

HSMN NewsFeed - 25 May 2006
Thalomid(R) sNDA Granted FDA Approval For Treatment of Newly Diagnosed Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 May 2006
FDA Approves Duramed's SEASONIQUE(TM) Extended-Cycle Oral Contraceptive Company's Second Proprietary Extended-Cycle OC to be Available in July

HSMN NewsFeed - 25 May 2006
Teva Announces Tentative Approval of Simvastatin Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 25 May 2006
ABIOMED Receives FDA Approval to Commence IMPELLA 2.5 U.S. Trial
Devices Cardiology FDA

HSMN NewsFeed - 25 May 2006
Cardima Receives FDA Market Clearance for New Surgical Ablation System
Devices Cardiology Surgery FDA

HSMN NewsFeed - 25 May 2006
Genentech Submits Supplemental Biologics License Application for Avastin With Chemotherapy in First-Line Metastatic Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 May 2006
Spire Receives FDA Clearance to Market Coated Long-Term Dialysis Catheter
Devices FDA

HSMN NewsFeed - 25 May 2006
Encysive Pharmaceuticals Submits Complete Response to FDA for Thelin(TM) New Drug Application
Biopharmaceuticals

HSMN NewsFeed - 24 May 2006
Akorn, Inc. Announces Product Approval for Orphenadrine Citrate Injection
Biopharmaceuticals FDA

HSMN NewsFeed - 24 May 2006
Mylan Announces Tentative Approval for Sumatriptan Succinate Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 24 May 2006
Endologix Receives FDA Approval for Visiflex Delivery System
Devices FDA

HSMN NewsFeed - 23 May 2006
ALZA Corporation Receives FDA Approval for IONSYS(TM) (Fentanyl Iontophoretic Transdermal System)
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 23 May 2006
GE Healthcare Debuts High Performance, Laptop-Size Ultrasound System to Serve Emergency Departments
Devices FDA

HSMN NewsFeed - 23 May 2006
Varian Medical Systems Receives FDA 510(k) Clearance on New Trilogy Tx(TM) and Trilogy(TM) Treatment Machines for Expanded Range of Medical Conditions
Devices Oncology FDA

HSMN NewsFeed - 23 May 2006
Halozyme Therapeutics Announces FDA 510(k) Clearance for MediCult's SynVitro Cumulase Product
Biopharmaceuticals FDA

HSMN NewsFeed - 22 May 2006
Draeger Medical files 510(k) Pre-market Notification for New Patient-worn Monitoring System
Devices Monitoring FDA

HSMN NewsFeed - 22 May 2006
Teva Announces Approval of Generic Lexapro(R) Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 22 May 2006
Hana Biosciences Receives Orphan Drug Designation for Talotrexin (PT-523), For the Treatment of Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 May 2006
SureTek Medical Receives Four Clearances from FDA Office of Device Evaluation
Devices Surgery FDA

HSMN NewsFeed - 22 May 2006
ADVENTRX Receives FDA Clearance Under a Special Protocol Assessment to Initiate CoFactor Phase III Clinical Trial
Biopharmaceuticals Oncology

HSMN NewsFeed - 22 May 2006
FDA Grants Fast Track Designation to Nektar's Amphotericin B Inhalation Powder (ABIP) for Prevention of Pulmonary Fungal Infections in At-Risk Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 22 May 2006
BSD Medical Corp.'s PMAA for the BSD-2000 Accepted for Filing by FDA
Devices FDA

HSMN NewsFeed - 19 May 2006
CDC Report Supports Bausch & Lomb's Decision to Recall MoistureLoc(R) Solution, Only Product Associated with Unusual Increase in Fusarium Infections
Devices Ophthalmology FDA

HSMN NewsFeed - 19 May 2006
Nexa Orthopedics Receives FDA Clearance to Market Pyrolytic Carbon Implant
Devices Orthopaedic FDA

HSMN NewsFeed - 19 May 2006
BIOTRONIK Announces Food and Drug Administration Approvable Status for Revolutionary Heart Failure Therapy System
Devices Cardiology FDA

HSMN NewsFeed - 18 May 2006
FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of GARDASIL(R), Merck's Investigational Cervical Cancer Vaccine
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 May 2006
FDA Advisory Committee Recommends Approval of Exelon(R) (rivastigmine tartrate) in the Treatment of Dementia Associated with Parkinson's Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 17 May 2006
AZILECT(R) FDA Approval Brings New Hope to People Living With Parkinson's Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 17 May 2006
Synovics Pharmaceuticals, Inc. Announces Acquisition of its First Application for Approval of a Generic Drug with the FDA
Biopharmaceuticals Generics Licensing

HSMN NewsFeed - 17 May 2006
Bausch & Lomb Clarifies Reporting of Fusarium Keratitis Cases to FDA
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 17 May 2006
Teva Announces FDA Grants Approval of AZILECT(R) (Rasagiline) for Parkinson's Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 17 May 2006
St. Jude Medical Announces FDA Approval, FDA Clearance and European CE Mark of New Electrophysiology Products
Devices Cardiology FDA

HSMN NewsFeed - 17 May 2006
Cordis Corporation Submits Pre-Market Approval Supplement for Direct Stenting
Devices Interventional Cardiology FDA

HSMN NewsFeed - 17 May 2006
Neotropix Receives FDA Approval to Begin Clinical Trials With First Investigational Cancer Drug
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 May 2006
Medtronic Receives FDA Approval for New Cardiac Systems with Distance Wireless Telemetry
Devices Cardiology FDA

HSMN NewsFeed - 17 May 2006
Biosite(R) Incorporated to Withdraw Triage(R) Stroke Panel PMA
Diagnostics FDA

HSMN NewsFeed - 16 May 2006
FDA Gives Permission to Use Very Sensitive Molecular Evidence of Cancer in BiovaxID Pivotal Phase 3 Clinical Trial
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 May 2006
Nymox Reports Positive New Efficacy Data for Benign Prostatic Hyperplasia Drug
Biopharmaceuticals Urology FDA

HSMN NewsFeed - 16 May 2006
BioElectronics Corporation Announces New 510(k) Market Clearance Application Filed With FDA
Devices FDA

HSMN NewsFeed - 16 May 2006
St. Jude Medical Announces FDA Approval of Epic II ICD and Epic II Heart Failure Devices
Devices Cardiology FDA

HSMN NewsFeed - 16 May 2006
Sysmex Receives FDA Clearance for New Hematology Analyzer
Diagnostics FDA

HSMN NewsFeed - 16 May 2006
Marshall Edwards Achieves Special Protocol Assessment and Agreement With FDA on Phase III (Ovature Study) of Phenoxodiol as a Chemosensitizing Agent in Women With Platinum-Resistant Ovarian Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 May 2006
Thoratec Receives FDA Approval of Continued Access Protocol for Bridge Arm of Its HeartMate(R) II Pivotal Trial
Devices Cardiology

HSMN NewsFeed - 16 May 2006
Valeant Pharmaceuticals Receives FDA Marketing Approval for Cannabinoid Cesamet(TM) (CII)
Biopharmaceuticals FDA

HSMN NewsFeed - 16 May 2006
Neurocrine Receives Approvable Letter for indiplon Capsules and Non-Approvable for indiplon Tablets for the Treatment of Insomnia
Biopharmaceuticals FDA

HSMN NewsFeed - 16 May 2006
Micrus Endovascular Receives FDA Clearance for Courier Microcatheter
Devices Interventional FDA

HSMN NewsFeed - 16 May 2006
Sorin Group Announces FDA Approval of World's Smallest Implantable Cardioverter Defibrillator; OVATIO(TM) Offers Advanced Pacing and Defibrillation Technology to Patients at Risk for Sudden Cardiac Arrest
Devices Cardiology FDA

HSMN NewsFeed - 15 May 2006
Dyax Provides Update on Regulatory Pathway for DX-88
Biopharmaceuticals FDA

HSMN NewsFeed - 15 May 2006
St. Jude Medical Announces FDA Clearance of EnSite(R) System 6 Software for Cardiac Mapping and Navigation
Devices Cardiology FDA

HSMN NewsFeed - 15 May 2006
U.S. FDA Grants Orphan Drug Designation to OXiGENE's Lead Clinical Candidate, Combretastatin A4P (CA4P), for the Treatment of Ovarian Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 15 May 2006
Advancis Pharmaceutical Receives FDA Approval Letter for New Strengths of Keflex
Biopharmaceuticals FDA

HSMN NewsFeed - 12 May 2006
Barr Receives Approval for Isotretinoin Capsules USP, 30 mg
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 12 May 2006
Given Imaging's Agile(TM) Patency System Receives US Marketing Clearance
Devices Gastroenterology FDA

HSMN NewsFeed - 11 May 2006
FDA Grants Accentia Biopharmaceuticals, Inc.'s Majority-Owned Subsidiary Fast Track Status for BiovaxID(TM)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 May 2006
Pfizer's Smoking Cessation Medicine Chantix(TM) (Varenicline) Receives FDA Approval
Biopharmaceuticals FDA

HSMN NewsFeed - 11 May 2006
Cordis Corporation Submits Pre-Market Approval Submission for Reblockage in Coronary Stent
Devices Interventional Cardiology FDA

HSMN NewsFeed - 11 May 2006
Micrus Endovascular Receives FDA Clearance for Watusi Guidewire
Devices Interventional FDA

HSMN NewsFeed - 10 May 2006
GE Healthcare Introduces the World's First and Only Compact Ultrasound System with 4D Imaging Capabilities
Devices Radiology FDA

HSMN NewsFeed - 10 May 2006
Boston Scientific and BioForm Medical Announce FDA Approval of Coaptite(R) Injectable Implant
Devices Urology FDA

HSMN NewsFeed - 10 May 2006
The Shape of Things to Come: Gender Solutions(TM) High-Flex Knee is the First Knee Replacement Shaped to Fit a Woman's Anatomy
Devices Orthopaedic FDA

HSMN NewsFeed - 10 May 2006
Biovest's AutovaxID(TM) Cleared for Commercial Sale
Biopharmaceuticals Devices FDA

HSMN NewsFeed - 10 May 2006
Smith & Nephew Receives FDA Approval for BIRMINGHAM HIP(TM) Resurfacing System
Devices Orthopaedic FDA

HSMN NewsFeed - 9 May 2006
FDA Approves 'IDE' Clinical Trial of Paradigm Spine's Coflex(TM) Functionally Dynamic Interspinous Implant
Devices FDA Neurosurgery Orthopaedic

HSMN NewsFeed - 9 May 2006
Baxter Receives FDA Approval for Ultra-High Dosage Strength of ADVATE for Hemophilia A
Biopharmaceuticals FDA

HSMN NewsFeed - 9 May 2006
Lilly Submits Cymbalta(R) Supplemental New Drug Application for Generalized Anxiety Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 9 May 2006
Novadaq receives FDA clearance for SPY labeling changes
Devices Surgery Cardiology FDA

HSMN NewsFeed - 9 May 2006
Aradigm Receives FDA Orphan Drug Designation of Liposomal Ciprofloxacin for Cystic Fibrosis
Biopharmaceuticals FDA

HSMN NewsFeed - 8 May 2006
Medicis Announces FDA Approval of SOLODYN -- minocycline HCl, USP -- Extended Release Tablets
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 8 May 2006
Alcon Gains FDA Approval for LADAR6000(TM) Excimer Laser and Wavefront-Guided Hyperopia
Devices Ophthalmology FDA

HSMN NewsFeed - 8 May 2006
Introgen's ADVEXIN p53 Therapy Provided to Cancer Patients With Li-Fraumeni Syndrome
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 May 2006
Med Enclosure, LLC - Management Discussion and Analysis of Food and Drug Administration Compliance
Devices Interventional FDA

HSMN NewsFeed - 8 May 2006
FDA Clears Valleylab's Cool-tip(TM) RF Ablation System for Use in Ablating Non-Resectable Liver Tumors
Devices Surgery Oncology FDA

HSMN NewsFeed - 8 May 2006
Cytogen Announces FDA Clears IND for CYT-500, a Monoclonal Antibody for the Treatment of Metastatic Hormone-Refractory Prostate Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 May 2006
Accentia Biopharmaceuticals Receives FDA Approval for Three Unique Dosage Combination Pain Product ANDAs
Biopharmaceuticals FDA

HSMN NewsFeed - 8 May 2006
Oxford BioSignals Receives FDA Approval for BioSign(TM) Technology
Devices Monitoring FDA

HSMN NewsFeed - 8 May 2006
Ascent Healthcare Solutions Receives 510(k) Clearances for Compression Sleeves
Devices FDA

HSMN NewsFeed - 7 May 2006
Teva Announces Approval of Polyethylene Glycol 3350 NF for Oral Solution
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 5 May 2006
U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) Supplemental Biologics License Application (sBLA) for Third-Party Manufacturing Facility Lonza Biologics Inc.
Biopharmaceuticals FDA

HSMN NewsFeed - 5 May 2006
Irvine Scientific Launches Innovative In Vitro Fertilization Freezing Product, First in the World
Devices FDA

HSMN NewsFeed - 4 May 2006
Hologic Receives FDA Clearance to Use Discovery DXA System for Detecting Cardiovascular Disease
Diagnostics Radiology Cardiology FDA

HSMN NewsFeed - 4 May 2006
FDA Confirms No Drugs are Therapeutically Equivalent to BiDil(R)
Biopharmaceuticals Cardiology Generics FDA

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