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

Healthcare News Roundup: FDA

HSMN NewsFeed - 12 Oct 2006
Agennix Receives FDA Orphan Drug Designation for Talactoferrin Alfa in Renal Cell Carcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Oct 2006
FDA Approves Avastin(R) in Combination With Chemotherapy for First-Line Treatment of Most Common Type of Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Oct 2006
Vascular Solutions Announces Expanded Indications For D-Stat Dry Hemostatic Bandage
Devices Interventional FDA

HSMN NewsFeed - 11 Oct 2006
EPOCAL Receives FDA Approval to Market the EPOCTM Blood Analysis System
Devices Diagnostics FDA

HSMN NewsFeed - 11 Oct 2006
GSK Submits Supplemental Drug Application for Advair in COPD
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Oct 2006
The US Food and Drug Administration Clears Syneron's LiteTouch Dental Laser for a Wide Range of Hard and Soft Tissue Procedures
Devices FDA

HSMN NewsFeed - 10 Oct 2006
MacroGenics Receives Orphan Drug Designation From FDA for Monoclonal Antibody to Treat Type 1 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 9 Oct 2006
Medtronic Receives FDA Approval to Study INFUSE Bone Graft in the Cervical Spine
Devices Orthopaedic Neurosurgery

HSMN NewsFeed - 9 Oct 2006
FDA Approves ZOLINZA(TM) (Vorinostat) for the Treatment of Cutaneous Manifestations in Patients with Cutaneous T-Cell Lymphoma Who Have Tried and Failed Other Therapies
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Oct 2006
Possis Medical Inc. Receives FDA Approval for Fetch(TM) Aspiration Catheter
Devices FDA Interventional

HSMN NewsFeed - 7 Oct 2006
FDA Approves ZOLINZA(TM) (Vorinostat) for the Treatment of Cutaneous Manifestations in Patients with Cutaneous T-Cell Lymphoma Who Have Tried and Failed Other Therapies
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Oct 2006
FDA Approves Sepracor's BROVANA(TM) (Arformoterol Tartrate) Inhalation Solution for Chronic Obstructive Pulmonary Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Oct 2006
New River Pharmaceuticals Inc. Receives Approvable Letter for NRP104
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Oct 2006
FDA Approves RISPERDAL(R) for Treatment of Irritability Associated with Autistic Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Oct 2006
Genta Receives Special Protocol Assessment from FDA for Randomized Trial of Genasense(R) Plus Chemotherapy in Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 6 Oct 2006
Wyeth Submits NDA and MAA for Torisel for the Treatment of Advanced Renal Cell Carcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 5 Oct 2006
Gen-Probe Receives FDA Approval for APTIMA(R) HIV-1 RNA Qualitative Assay for Clinical Diagnostic Use
Diagnostics FDA

HSMN NewsFeed - 5 Oct 2006
Masimo Announces FDA Clearance of Radical-7, First Bedside Monitor with the Breakthrough Rainbow Technology
Devices FDA Monitoring

HSMN NewsFeed - 5 Oct 2006
GSK's New Flu Vaccine, FluLaval(TM), Provides Americans With a New Option for Fighting the Flu
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Oct 2006
FDA Approves New Drug Application for 3M DuraPrep Surgical Solution
Biopharmaceuticals Surgery FDA

HSMN NewsFeed - 5 Oct 2006
Agennix Receives FDA Fast Track Designation for Talactoferrin Alfa in Non-Small Cell Lung Cancer and Diabetic Foot Ulcers
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 5 Oct 2006
FDA Approves New Label for VYTORIN(R) (ezetimibe/simvastatin)
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Oct 2006
FDA Approves New Indication for YAZ(R) to Treat Emotional and Physical Symptoms of Premenstrual Dysphoric Disorder (PMDD)
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Oct 2006
Dako Receives FDA Approval for Use of EGFR pharmDx(TM) With Vectibix(TM)
Diagnostics FDA Oncology

HSMN NewsFeed - 4 Oct 2006
Gen-Probe Receives FDA License for PROCLEIX(R) ULTRIO(R) Assay
Diagnostics FDA

HSMN NewsFeed - 4 Oct 2006
Arixtra(R) Receives Priority Review by the FDA in Acute Coronary Syndromes (ACS)
Biopharmaceuticals Cardiology Generics

HSMN NewsFeed - 3 Oct 2006
FDA Approves Medafor's Arista(TM) AH Absorbable Surgical Hemostat for U.S. Operating Rooms
Devices Surgery FDA

HSMN NewsFeed - 3 Oct 2006
Allos Therapeutics Receives FDA Fast Track Designation for PDX for the Treatment of T-cell Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Oct 2006
EpiCept Announces IND Filing of Novel Compound with Potent Apoptotic and Tumor Selective Vascular Disruptive Activity for Treatment of Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Oct 2006
FDA Grants Priority Review for ARIXTRA(R) (fondaparinux sodium) in the Treatment of Acute Coronary Syndromes
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 2 Oct 2006
Cytori Therapeutics Achieves 510(k) Clearance for the Celution(TM) System
Devices Surgery FDA

HSMN NewsFeed - 2 Oct 2006
CardiacAssist Wins FDA Approval for TandemHeart(R) Escort Controller
Devices Cardiology FDA

HSMN NewsFeed - 2 Oct 2006
Avantogen Oncology Inc. Files IND Application for RP101
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Oct 2006
Boston Scientific Announces Major Expansion of its LATITUDE(R) Patient Management System
Devices Cardiology FDA

HSMN NewsFeed - 29 Sep 2006
FDA Approves Two New Indications for Rituxan(R) in Patients With Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Sep 2006
FDA Issues Approvable Letter for Paliperidone ER for the Treatment of Schizophrenia
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Sep 2006
Medtronic Comment on FDA Warning Letter
Devices Interventional FDA

HSMN NewsFeed - 29 Sep 2006
Bayer Acknowledges That New Trasylol Study Was Not Disclosed Prior to Recent FDA Cardio-Renal Advisory Committee Meeting
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 29 Sep 2006
Axcan Receives FDA Approval Letter for PYLERA'TM' -Formerly Known as HELIZIDE-, an Innovative 3-in-1 Capsule Triple Therapy for the Eradication of Helicobacter Pylori
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 29 Sep 2006
FDA Issues Approvable Letter to Ortec for Use of Cryopreserved OrCel(R) in Epidermolysis Bullosa Patients' Hand Reconstructions and Donor Sites
Regenerative Medicine FDA

HSMN NewsFeed - 29 Sep 2006
Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of Diabetic Retinopathy
Biopharmaceuticals FDA Ophthalmology

HSMN NewsFeed - 29 Sep 2006
Labopharm receives approvable letter from FDA for once-daily tramadol
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 29 Sep 2006
BIOLASE Receives Notice That It Has Adequately Addressed the Concerns Raised in the FDA Warning Letter
Devices FDA

HSMN NewsFeed - 28 Sep 2006
Ikonisys Receives FDA Clearance for Prenatal Testing Application
Diagnostics FDA

HSMN NewsFeed - 28 Sep 2006
Medivation Receives FDA Permission to Begin Dimebon Huntington's Disease Trial
Biopharmaceuticals FDA Neurology

HSMN NewsFeed - 27 Sep 2006
FDA Approves Vectibix(TM) to Treat Patients with Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 27 Sep 2006
Life Recovery Systems Receives FDA Clearance for its ThermoSuit(R) System
Devices FDA

HSMN NewsFeed - 27 Sep 2006
Life Spine Announces FDA Approval of Four New Products at Annual Meeting of North American Spine Society
Devices Orthopaedic Neurosurgery

HSMN NewsFeed - 27 Sep 2006
Kensey Nash Announces 510(K) Clearance for Proprietary Bone Void Filler
Devices Orthopaedic FDA

HSMN NewsFeed - 27 Sep 2006
FDA Approves Clinical Trial For Medtronic's DIAM Spinal Stabilization System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 27 Sep 2006
FDA Approves REMICADE(R) for Treatment of Chronic Severe Plaque Psoriasis: Marks Major Milestone for Patients With High Disease Burden
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Sep 2006
Colazal(R) Food Effect Application Granted FDA Approval
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 27 Sep 2006
Boston Scientific Announces FDA Approval of Harmony(TM) HiResolution(R) Bionic Ear System
Devices FDA

HSMN NewsFeed - 27 Sep 2006
Pervasis Therapeutics' Vascugel(TM) Initiates U.S. Clinical Trials Following Successful FDA IND Review
Regenerative Medicine FDA

HSMN NewsFeed - 26 Sep 2006
Exactech Gains FDA Clearance for DBM with Bone Chips, Optecure(TM)+CCC
Devices Orthopaedic FDA

HSMN NewsFeed - 26 Sep 2006
Callisto Pharmaceuticals Granted Orphan Drug Designation for Atiprimod to Treat Carcinoid Tumors
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 26 Sep 2006
Ascent Healthcare Receives 510(k) Clearance on Medtronic TORQR CS Series Catheters
Devices Cardiology FDA

HSMN NewsFeed - 26 Sep 2006
U.S. Food and Drug Administration Approves New Medical Devices to Treat Clogged Neck Arteries
Devices Interventional FDA

HSMN NewsFeed - 25 Sep 2006
Cephalon Receives FDA Approval of FENTORA(TM) (fentanyl buccal tablet) for the Management of Breakthrough Pain in Patients with Cancer
Biopharmaceuticals Oncology Drug Delivery FDA

HSMN NewsFeed - 25 Sep 2006
BIO Joins Coalition to Strengthen FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Sep 2006
Medtronic Announces FDA 510(k) Clearance of Next-Generation Export(R) XT Aspiration Catheter
Devices Interventional FDA

HSMN NewsFeed - 25 Sep 2006
FDA Approves New Epilepsy Indication For Lamictal(R)
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 22 Sep 2006
Greenwood Releases Statement on IOM Drug Safety Document
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Sep 2006
Oscient Pharmaceuticals Receives Approvable Letter from FDA for FACTIVE(R) Tablets for Five-Day Treatment of Community-Acquired Pneumonia
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Sep 2006
DOR BioPharma Files New Drug Application with FDA to Market orBec for GI GVHD
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Sep 2006
Alcon's TRAVATAN(R) Z Solution Approved by FDA for Treatment of Glaucoma and Ocular Hypertensive Patients
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 21 Sep 2006
FDA Advisory Committee Strongly Endorses Use of Trasylol(R) in CABG Surgery Patients
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 21 Sep 2006
Vital Signs, Inc. Announces FDA Clearance to Market Sleep and Ventilation Products
Devices FDA

HSMN NewsFeed - 21 Sep 2006
Ranbaxy Receives Approval to Commercialize Furosemide Tablets in the U.S.
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 21 Sep 2006
Spire Receives FDA Clearance to Market Nanocrystalline, Silver Coated, Long-Term Dialysis Catheters
Devices FDA

HSMN NewsFeed - 21 Sep 2006
Serono's Oral Cladribine for the Treatment of Multiple Sclerosis Awarded Fast Track Status by FDA
Biopharmaceuticals FDA Neurology

HSMN NewsFeed - 20 Sep 2006
Gen-Probe Responds to FDA Questions on TIGRIS(R) / West Nile Virus Regulatory Application
Diagnostics FDA

HSMN NewsFeed - 20 Sep 2006
Medwave's Fusion(TM) Granted 510(k) Clearance by FDA
Devices Monitoring FDA

HSMN NewsFeed - 19 Sep 2006
FDA Approves Connetics' Verdeso Foam for the Treatment of Mild-to-Moderate Atopic Dermatitis
Biopharmaceuticals Dermatology Drug Delivery FDA

HSMN NewsFeed - 19 Sep 2006
FDA Panel Unanimously Recommends Approval of Medtronic's New PRESTIGE(R) Cervical Disc System
Devices FDA Neurosurgery Orthopaedic

HSMN NewsFeed - 19 Sep 2006
St. Jude Medical Announces FDA and European CE Mark Approvals of Tendril ST(R) Pacemaker Lead
Devices Cardiology Regulatory

HSMN NewsFeed - 19 Sep 2006
QuantRx(R) Biomedical Appoints Former FDA Commissioner Dr. Arthur Hull Hayes, Jr. to Board of Directors
Diagnostics Personnel

HSMN NewsFeed - 19 Sep 2006
Dermik Laboratories Announces FDA Acceptance of Supplemental Filing Application for Sculptra(R)
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 19 Sep 2006
Derma Sciences Receives FDA Approval for Its Next-Generation Antimicrobial Silver Alginate Wound Dressing
Devices Wound Care

HSMN NewsFeed - 18 Sep 2006
FDA Approves Center Expansion of Cardiovascular Systems, Inc. Clinical Trial of the Orbital Atherectomy System
Devices Interventional FDA

HSMN NewsFeed - 18 Sep 2006
Schering-Plough Announces FDA Approval of NOXAFIL(R) (Posaconazole) for Prevention of Invasive Fungal Infections
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Sep 2006
Quidel Announces FDA 510(k) Clearance of Their New Rapid Test for Detection of Respiratory Syncytial Virus (RSV)
Diagnostics FDA

HSMN NewsFeed - 18 Sep 2006
FDA Approves Lechnologies' AfibAlert(TM) Atrial Fibrillation Monitor
Devices FDA Monitoring

HSMN NewsFeed - 14 Sep 2006
Boston Scientific Welcomes FDA Statement on Drug-Eluting Stents
Devices Interventional Cardiology FDA

HSMN NewsFeed - 14 Sep 2006
Lupin Announces Approval of Ceftriaxone 10G Vials
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 13 Sep 2006
Uroplasty Receives FDA Approvable Letter for Macroplastique
Devices Urology FDA

HSMN NewsFeed - 13 Sep 2006
Oscient Pharmaceuticals Announces Results of FDA Advisory Committee Meeting for FACTIVE Tablets for the Treatment of Acute Bacterial Sinusitis
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Sep 2006
Advancis Pharmaceutical On Track to File NDA for Amoxicillin PULSYS
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Sep 2006
KV Pharmaceutical Company Receives ANDA Approval From U.S. FDA for Six Strengths of Diltiazem HCl ER Capsules
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 12 Sep 2006
Mylan Announces Final FDA Approval for Topiramate Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 12 Sep 2006
Endocare Receives FDA 510K Clearance to Market New Nitrogen-Based Cryoablation System for Destroying Tissue and Cancerous Tumors
Devices FDA

HSMN NewsFeed - 11 Sep 2006
BIOLASE Comments on Receipt of FDA Warning Letter
Devices FDA

HSMN NewsFeed - 11 Sep 2006
Ranbaxy Receives FDA Approval to Market Loperamide Hydrochloride and Simethicone Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 8 Sep 2006
Taro Announces Filing Of ANDA For Oxcarbazepine Tablets 150, 300 And 600 MG
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 8 Sep 2006
Shire Provides Update on U.S. Marketing Application of MESAVANCE(TM) (mesalamine) With MMX Technology
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 7 Sep 2006
CAS Medical Systems, Inc. Announces FDA 510(k) Clearance for Expanded Use of FORE-SIGHT(TM) Cerebral Oximeter
Devices Monitoring FDA

HSMN NewsFeed - 7 Sep 2006
Abbott Submits U.S. and E.U. Regulatory Applications Seeking Approval for HUMIRA(R) (Adalimumab) as a Treatment for Crohn's Disease
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 7 Sep 2006
Watson Pharmaceuticals Receives FDA Final Approval for Generic Seasonale(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 6 Sep 2006
ZOLL Receives FDA Marketing Clearance for New Hospital Device
Devices FDA

HSMN NewsFeed - 6 Sep 2006
OVATION and Cardinal Health Announce FDA Approval Letter for Manufacturing of Biologic Therapy To Treat Rare Genetic Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Sep 2006
FDA Grants Humanitarian Use Device Designation to Cyberkinetics' Andara(TM) OFS Device for Acute Spinal Cord Injuries
Devices FDA Neurosurgery

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