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

Healthcare News Roundup: FDA

HSMN NewsFeed - 24 Mar 2009
Perrigo Announces FDA Approval for Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 24 Mar 2009
Biodel to Submit New Drug Application for VIAject to FDA
Biopharmaceuticals Endocrinology

HSMN NewsFeed - 24 Mar 2009
FDA Approves New Indication for Wyeth's TYGACIL (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Mar 2009
Celsion Receives Orphan Drug Designation for ThermoDox to Treat Primary Liver Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 24 Mar 2009
Gore Receives FDA Approval for Larger Diameter, Small Profile AAA Endoprosthesis
Devices Interventional FDA

HSMN NewsFeed - 23 Mar 2009
U.S. FDA Approves New THERAKOS(TM) CELLEX(TM) Photopheresis System
Devices Oncology FDA

HSMN NewsFeed - 23 Mar 2009
Morphotek(R), Inc. and Eisai Corporation of North America Announce FDA Special Protocol Assessment (SPA) for Phase III Trial Evaluating Farletuzumab in Relapsed Ovarian Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 23 Mar 2009
U.S. Naval Medical Research Center Resubmits IND Application for Proposed 'RESUS' Clinical Trial in Trauma Patients in the Out-of-Hospital Setting
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Mar 2009
FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Mar 2009
Covidien Receives FDA Clearance for the Nellcor OxiMax N-600x Pulse Oximeter with OxiMax SPD Alert
Devices Monitoring FDA

HSMN NewsFeed - 23 Mar 2009
Skyepharma PLC Announces Regulatory Application
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Mar 2009
Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward to Resume Oxycyte Clinical Trials in TBI in U.S.A.
Devices FDA

HSMN NewsFeed - 19 Mar 2009
OSI Pharmaceuticals Submits Supplemental New Drug Application to the FDA for Tarceva as a First-Line Maintenance Therapy in Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Mar 2009
FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 18 Mar 2009
Medivation Receives FDA Permission to Initiate Phase 3 Trial of MDV3100 in Castration-Resistant Prostate Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Mar 2009
Flexible Stenting Solutions, Inc. Announces IDE Submission for FlexStent(R) Femoropopliteal Self Expanding Stent System
Devices Interventional FDA

HSMN NewsFeed - 17 Mar 2009
Perrigo and Partner Cobrek Confirms Filing for Generic Version of Evoclin(R) and Announcement of Lawsuit by Stiefel
Biopharmaceuticals Generics Litigation FDA

HSMN NewsFeed - 16 Mar 2009
United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 16 Mar 2009
Spectrum Pharmaceuticals Acquires 100% of ZEVALIN, an FDA-Approved, Proprietary, Biological Drug for Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology Acquisitions

HSMN NewsFeed - 16 Mar 2009
Orexo's Edluar (Sublinox) Receives FDA Approval for the Treatment of Insomnia
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Mar 2009
FDA Approves Two Hologic HPV Tests
Diagnostics FDA

HSMN NewsFeed - 12 Mar 2009
HemAway(R) Launches FDA-Cleared Painless Hemorrhoid Treatment Device
Devices

HSMN NewsFeed - 12 Mar 2009
Orbital Therapy Receives 510(k) Clearance for the Clearvue(TM) Prone Position Breast Radiotherapy Treatment Table
Devices Oncology FDA

HSMN NewsFeed - 12 Mar 2009
FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Mar 2009
Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for First Generic, Heat-Stable Version of HIV Protease Inhibitor
Biopharmaceuticals Generics FDA HIV/AIDS

HSMN NewsFeed - 12 Mar 2009
I-Flow Corporation Receives FDA Clearance for Stabilized Antimicrobial Wound Gel
Biopharmaceuticals Wound Care FDA

HSMN NewsFeed - 11 Mar 2009
FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Mar 2009
Molecular Insight Receives Special Protocol Assessment Approval From FDA for Phase 2 Trial of Azedra(TM), a Radiotherapeutic to Treat Neuroendocrine Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Mar 2009
CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Mar 2009
FDA Classifies Recent Urgent Device Correction on Baxter's COLLEAGUE Infusion Pump as a Class I Recall
Devices Product Recall FDA

HSMN NewsFeed - 11 Mar 2009
Female Health Company Receives FDA Approval for FC2 Female Condom(R)
Devices FDA

HSMN NewsFeed - 10 Mar 2009
FDA Grants Orphan Drug Designation for EUR-1073
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 9 Mar 2009
FDA Approves SyntheMed's REPEL-CV(R) Adhesion Barrier for Use in Pediatric Cardiac Surgery
Devices Surgery Cardiology FDA

HSMN NewsFeed - 7 Mar 2009
FDA Appeal Decision Indicates that Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 5 Mar 2009
BSD Files Humanitarian Use Petition With FDA for Marketing Approval for the BSD-2000 Hyperthermia System
Devices Oncology FDA

HSMN NewsFeed - 5 Mar 2009
European Commission and United States Food and Drug Administration (FDA) Both Approve New Options for Patients With Certain Primary Brain Tumors
Biopharmaceuticals Oncology FDA Regulatory

HSMN NewsFeed - 4 Mar 2009
FDA Accepts Investigational New Drug (IND) Application for Tigris Pharmaceutical's GGTI-2418
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Mar 2009
FDA Clears New Skin and Surface Treatment Applicator for Use With Xoft's Axxent(R) Electronic Brachytherapy (eBx) System
Devices Oncology FDA

HSMN NewsFeed - 3 Mar 2009
Texas Cardiac Arrhythmia Institute at St. David's Medical Center First in Nation to Use NaviStar(R) RMT ThermoCool(R) Catheter Since Technology Received FDA Approval
Devices Cardiology

HSMN NewsFeed - 2 Mar 2009
ImClone Systems and Bristol-Myers Squibb Update Status of First-Line Squamous Cell Carcinoma of the Head and Neck Supplemental Biologics Application for ERBITUX(R) in U.S.
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 27 Feb 2009
Stereotaxis Announces FDA Approval of the NAVISTAR(R) RMT THERMOCOOL(R) Catheter
Devices FDA

HSMN NewsFeed - 27 Feb 2009
Derma Sciences Gains FDA Clearance for Novel BIOGUARD(TM) Barrier Dressing with NIMBUS(R) Technology
Devices Wound Care FDA

HSMN NewsFeed - 26 Feb 2009
FDA Approves Genzyme's Synvisc-One for Osteoarthritis of the Knee
Biopharmaceuticals FDA

HSMN NewsFeed - 26 Feb 2009
FDA Approves Apidra(R) SoloSTAR(R) - a Prefilled Disposable Insulin Pen
Biopharmaceuticals Drug Delivery Endocrinology FDA

HSMN NewsFeed - 25 Feb 2009
CUREXO Technology Corporation Announces 510(k) Submission to FDA for Total Knee Arthroplasty Application
Devices Orthopaedic

HSMN NewsFeed - 24 Feb 2009
Nephros Provides Update on 510k Applications
Devices FDA

HSMN NewsFeed - 23 Feb 2009
Neuisys Announces FDA Clearance of NeuViz 16 Multi-Slice CT System
Devices Radiology FDA

HSMN NewsFeed - 23 Feb 2009
Oridion Receives FDA 510(k) Clearance for Capnostream(TM)20 Monitor With Integrated Pulmonary Index(TM)
Devices FDA

HSMN NewsFeed - 20 Feb 2009
Schering-Plough Submits Response to FDA for SAPHRIS(TM) (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder
Biopharmaceuticals

HSMN NewsFeed - 19 Feb 2009
Medtronic Receives FDA HDE Approval to Commercialize the First Deep Brain Stimulation (DBS) Therapy for a Psychiatric Indication in the United States
Devices Neurology

HSMN NewsFeed - 19 Feb 2009
FDA Accepts Nuvo's Resubmission For Pennsaid(R)
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 18 Feb 2009
Gilead Receives Response From U.S. FDA on Company's Request for Formal Dispute Resolution for Aztreonam for Inhalation Solution
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 17 Feb 2009
SafeStitch Medical, Inc. Announces FDA Approval to Market Its SMART Dilator(TM)
Devices Gastroenterology FDA

HSMN NewsFeed - 17 Feb 2009
Cipher receives tentative FDA approval for extended-release tramadol capsules
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 17 Feb 2009
Cardinal Health, FDA Amend Infusion Pump Consent Decree
Devices FDA

HSMN NewsFeed - 17 Feb 2009
FDA Clears New Immune Response Claim for the CryoValve(R) SG Pulmonary Human Heart Valve
Devices Cardiology FDA

HSMN NewsFeed - 17 Feb 2009
Bard Receives FDA Approval for the LifeStent Vascular Stent
Devices Interventional FDA

HSMN NewsFeed - 17 Feb 2009
Newly Published Menopause Study: 'Bioidentical' and FDA-Approved Divigel(R) (estradiol gel) 0.1 Percent Safe and Effective Treatment for Moderate to Severe Hot Flashes Associated With Menopause
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 17 Feb 2009
Avantis Medical Systems Announces FDA 510(k) Clearance for the Third Eye(R) Retroscope(R) for Improved Polyp Detection in the Colon
Devices Gastroenterology FDA

HSMN NewsFeed - 14 Feb 2009
FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Feb 2009
Father of World's Only FDA & CE Approved Total Artificial Heart Dies at 97
Devices Cardiology Personnel

HSMN NewsFeed - 11 Feb 2009
Transoma Medical Receives FDA Marketing Clearance for Sleuth AT Implantable Cardiac Monitoring System
Devices Cardiology Monitoring

HSMN NewsFeed - 11 Feb 2009
Sensiotec Announces FDA 510(k) Class II Clearance for the World's First UWB Healthcare Unbound, Wireless, Non-Contact, Vital Signs and Movement Monitor
Devices Monitoring FDA

HSMN NewsFeed - 11 Feb 2009
Abbott Receives FDA Clearance for New CELL-DYN(R) Emerald(TM) Hematology Instrument
Diagnostics FDA

HSMN NewsFeed - 11 Feb 2009
Genta Submits Randomized Study of Tesetaxel in Patients with Advanced Gastric Cancer to FDA for Special Protocol Assessment
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Feb 2009
FDA Issues Complete Response Letter for RISPERDAL(R) CONSTA(R) for the Adjunctive Maintenance Treatment of Bipolar Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Feb 2009
Teva Announces Approval and Launch of Generic Imitrex(R) Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 10 Feb 2009
SurgiQuest Announces FDA Approval for Smoke & Plume Evacuation for AirSeal Dynamic Pressure System(TM)
Devices Surgery FDA

HSMN NewsFeed - 10 Feb 2009
Guided Therapeutics, Inc. Reports Preliminary Findings from FDA Pivotal Clinical Trial
Devices Diagnostics Oncology

HSMN NewsFeed - 10 Feb 2009
Enzon Announces IND Acceptance for Its Survivin Antagonist
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Feb 2009
K2M Receives 510(k) Clearance for its tifix CAYMAN Plate Systems
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 10 Feb 2009
FDA Approves Clinical Studies of a Novel Anti-Cancer Drug Developed by Italian Researchers
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Feb 2009
ARKRAY USA Receives FDA Clearance on GLUCOCARD(R) 01-mini Blood Glucose Monitoring System
Devices Monitoring Endocrinology FDA

HSMN NewsFeed - 9 Feb 2009
GORE Flow Reversal System Cleared by FDA
Devices Interventional Neurology FDA

HSMN NewsFeed - 9 Feb 2009
Gore Receives FDA Approval for Modification to GORE TAG Thoracic Endoprosthesis
Devices Interventional FDA

HSMN NewsFeed - 6 Feb 2009
FDA Grants Marketing Approval to NAVISTAR(R) THERMOCOOL(R) Catheter for Atrial Fibrillation
Devices Cardiology FDA

HSMN NewsFeed - 6 Feb 2009
ROXRO Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 6 Feb 2009
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Feb 2009
St. Jude Medical Announces U.S. Approval of Industry's First Connector System Designed to Simplify Implant Process for Cardiac Resynchronization Therapy Devices
Devices Cardiology FDA

HSMN NewsFeed - 5 Feb 2009
Immunomedics' hPAM4 Labeled With Yttrium-90 Receives Fast Track Designation From FDA for Therapy of Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 5 Feb 2009
Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Lesion Stents
Devices Interventional Cardiology

HSMN NewsFeed - 5 Feb 2009
Dr. Reddy's Announces Five ANDA Approvals and Generic Product Launches in the US Market
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 4 Feb 2009
FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Feb 2009
Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 3 Feb 2009
FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Feb 2009
Galderma Wins FDA Approval for Vectical(TM) Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 2 Feb 2009
MedWaves, Inc. Announces Receipt of MDD CE Certification and Additional U.S. FDA 510(k) Clearance to Market Its Patented Microwave Coagulation/Ablation System and Devices
Devices Interventional Surgery Regulatory

HSMN NewsFeed - 2 Feb 2009
Pathway Medical Technologies Receives FDA 510(K) Clearance for Jetstream G2 System
Devices Interventional FDA

HSMN NewsFeed - 31 Jan 2009
FDA Approves KAPIDEX(TM) (Dexlansoprazole) Delayed Release Capsules for the Treatment of GERD
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 30 Jan 2009
Teva Announces Approval of Generic Risperdal(R) Oral Solution
Biopharmacueticals Generics FDA

HSMN NewsFeed - 30 Jan 2009
AdvanDx Receives FDA 510(k) Clearance for E. coli/P. aeruginosa PNA FISH(R)
Diagnostics FDA

HSMN NewsFeed - 30 Jan 2009
Mylan Receives FDA Approval for First-to-File Generic Depakote(R) ER
Biopharmacueticals Generics FDA

HSMN NewsFeed - 29 Jan 2009
FDA Accepts Eurand's Response to Approvable Letter for EUR-1008 as Complete
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Jan 2009
FDA Provides Clear Path to NDA Submission for Pro-Pharmaceuticals’ DAVANAT(R)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Jan 2009
POZEN Informed by FDA That Endoscopic Gastric Ulcer Incidence Continues to Be an Acceptable Primary Endpoint
Biopharmaceuticals FDA

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