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Healthcare News Roundup: FDA

 HSMN NewsFeed - 23 Feb 2010
FDA Advisory Committee Recommends Approval Of XIFAXAN(R) (rifaximin) Tablets, 550 Mg for Maintenance of Remission of Hepatic Encephalopathy
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Feb 2010
Instrumentation Laboratory Receives 510(K) Clearance From FDA and Canadian License for HemosIL(R) D-Dimer HS 500 Assay
Diagnostics FDA Regulatory
 HSMN NewsFeed - 23 Feb 2010
Forest Laboratories Receives Decision from FDA for Supplemental New Drug Application for Bystolic(R)
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 22 Feb 2010
Transcept Pharmaceuticals Provides Update on Intermezzo(R) Regulatory Review
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Feb 2010
FDA Approves Once-Daily MIRAPEX ER for the Treatment of Early Parkinson's Disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 22 Feb 2010
Syneron Receives FDA Clearance for Expanded Indications of eMatrix(TM) Sublative Rejuvenation System
Devices FDA
 HSMN NewsFeed - 22 Feb 2010
FDA Acknowledges Need for Daily Multiple Sclerosis Pill by Granting Fingolimod Priority Review Status
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 20 Feb 2010
FDA Classifies Prolia(TM) (Denosumab) Complete Response Submission and Targets Action Date
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Feb 2010
Novartis Drug Tasigna(R) Receives FDA Priority Review for Newly Diagnosed Patients With Early-Stage Chronic Myeloid Leukemia
Biopharmaceuticals Oncology
 HSMN NewsFeed - 18 Feb 2010
Sorin Group Announces U.S. FDA Clearance of Newest Generation Heart Lung-Machine
Devices Cardiology FDA
 HSMN NewsFeed - 17 Feb 2010
Otonomy Receives FDA Clearance to Initiate Clinical Trial in Patients with Meniere's Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Feb 2010
Centocor Ortho Biotech Products and Amgen Finalize ESA Risk Evaluation and Mitigation Strategy (REMS) With FDA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Feb 2010
FDA Grants Orphan Drug Status for Quark's QPI-1002 for the Prophylaxis of Delayed Graft Function in Kidney Transplant Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Feb 2010
Abbott Receives U.S. FDA Approval for Heat-Stable Norvir(R) (ritonavir) Tablets
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 11 Feb 2010
NewLink Genetics Receives Special Protocol Assessment Approval from FDA for Pivotal Phase 3 Trial in Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Feb 2010
FDA Approves Benicar(R) for the Treatment of High Blood Pressure in Children and Adolescents aged 6-16
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 11 Feb 2010
Cadence Pharmaceuticals Receives Complete Response Letter from FDA for Intravenous Acetaminophen NDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Feb 2010
Volcano Receives FDA Clearance to Market the Eagle Eye(R) Platinum Digital IVUS Catheter
Devices Interventional FDA
 HSMN NewsFeed - 8 Feb 2010
Lupin Receives FDA Approval for Amlodipine/Benazepril Capsules
Biopharmaceuticals FDA Generics
 HSMN NewsFeed - 8 Feb 2010
Sagent Pharmaceuticals Announces FDA Approval of Labetalol Hydrochloride Injection, USP
Biopharmaceuticals Generics Cardiology FDA
 HSMN NewsFeed - 8 Feb 2010
Abbott Submits New Automated Ovarian Cancer Test for U.S. Approval
Diagnostics Oncology FDA
 HSMN NewsFeed - 8 Feb 2010
Synovis Life Technologies Receives FDA Marketing Clearance for Flow Coupler(R)
Devices Surgery FDA
 HSMN NewsFeed - 8 Feb 2010
Anthera Pharmaceuticals Announces Agreement With the FDA on a SPA for Planned Phase 3 Varespladib A-002 Study; Daniel K. Spiegelman Joins Board of Directors
Biopharmaceuticals Cardiology Personnel
 HSMN NewsFeed - 5 Feb 2010
Novus Scientific Receives FDA Clearance for TIGR(TM) Matrix Surgical Mesh - World's 1st Long-Term Resorbable Synthetic Mesh
Devices FDA
 HSMN NewsFeed - 4 Feb 2010
Bioheart Launches First US FDA Approved Clinical Trial that Tests Gene-Modified Stem Cell Therapy in Patients with Congestive Heart Failure
Regenerative Medicine Cardiology
 HSMN NewsFeed - 4 Feb 2010
Toshiba Receives FDA Clearance for Viamo Ultrasound System
Devices Radiology
 HSMN NewsFeed - 3 Feb 2010
Medicis Receives Approval for RESTYLANE(R) and PERLANE(R) With Lidocaine
Devices Dermatology FDA
 HSMN NewsFeed - 2 Feb 2010
Auxilium Announces U.S. Food and Drug Administration Approval for XIAFLEX(TM) for the Treatment of Dupuytren's Contracture
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Feb 2010
Veran Medical Receives FDA Clearances to Expand Uses for ig4 Navigation System to Use Ultrasound and 3D Fluoroscopic X-ray
Devices Oncology FDA
 HSMN NewsFeed - 2 Feb 2010
FDA Accepts Javelin Pharmaceuticals' Submission and Files New Drug Application for Dyloject(TM)
Biopharmaceuticals FDA Mergers & Acquisitions
 HSMN NewsFeed - 1 Feb 2010
Pervasis Therapeutics Receives FDA Clearance for Pivotal Phase 3 Trial of Vascugel(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Jan 2010
GSK's TYKERB(R) Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Jan 2010
FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 29 Jan 2010
Mylan Receives Approval for Generic Version of GoLytely(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 28 Jan 2010
Lupin Receives U.S. FDA Approval For Perindopril Erbumine Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 28 Jan 2010
Aubrey Inc. Receives FDA Clearance for AWBAT Plus
Devices Wound Care FDA
 HSMN NewsFeed - 28 Jan 2010
Life Spine(R) Announces FDA Clearance of DYNA-LINK(R) Spinal System and PRESIDIO(TM) Spinal Plating System
Devices FDA Neurosurgery Orthopaedic
 HSMN NewsFeed - 28 Jan 2010
EnteroMedics Announces Regulatory Path Forward Following FDA Meeting
Devices Gastroenterology FDA
 HSMN NewsFeed - 27 Jan 2010
The PICC WAND from Access Scientific Receives FDA Clearance
Devices FDA
 HSMN NewsFeed - 27 Jan 2010
EpiCept Receives Orphan Drug Designation for EpiCept NP-1 in U.S.
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Jan 2010
Phadia Brings the First and Only Point of Care In Vitro Specific IgE Allergy Test into the Physician's Office with Final FDA Clearance of the ImmunoCAP(R) Rapid System
Diagnostics FDA
 HSMN NewsFeed - 26 Jan 2010
Novo Nordisk's Victoza(R) Receives FDA Approval for Adults With Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 26 Jan 2010
Medtronic Receives FDA Approval for First Replacement Heart Valve Implanted without Surgery
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 25 Jan 2010
Calibra Receives 510(k) Clearance for the Finesse Insulin Patch-Pen, a Novel Way to Deliver Insulin
Devices Drug Delivery Endocrinology FDA
 HSMN NewsFeed - 25 Jan 2010
Spectrum Pharmaceuticals Announces Results of FDA Meeting Regarding FUSILEV(R) sNDA under Review for Advanced Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Jan 2010
Biogen Idec Issues Statement on U.S. Approval of AMPYRA (dalfampridine)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 22 Jan 2010
Acorda Therapeutics Announces FDA Approval of AMPYRA (dalfampridine) to Improve Walking in People with Multiple Sclerosis - Demonstrated by Increases in Walking Speed
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 21 Jan 2010
Teva Announces Tentative Approval of Generic Femara(R) Tablets
Biopharmaceuticals Generics Oncology FDA
 HSMN NewsFeed - 21 Jan 2010
Lupin Receives US FDA Tentative Approval for Memantine HCl Tablets
Biopharmaceuticals Generics Neurology FDA
 HSMN NewsFeed - 21 Jan 2010
Abaxis Receives FDA 510K Clearance for a New
Diagnostics FDA
 HSMN NewsFeed - 20 Jan 2010
Thoratec Announces FDA Approval of HeartMate II(R) for Destination Therapy
Devices Cardiology FDA
 HSMN NewsFeed - 19 Jan 2010
Corventis Announces FDA Clearance and US Launch of the NUVANT Mobile Cardiac Telemetry System
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 19 Jan 2010
Invatec Receives 510(k) Clearance of REEF HP PTA Balloon Catheter
Devices Interventional FDA
 HSMN NewsFeed - 19 Jan 2010
ProGEL Lung Surgery Device Gets FDA Approval
Devices FDA
 HSMN NewsFeed - 18 Jan 2010
Theratechnologies Reports Date for FDA Advisory Committee Review of the Tesamorelin New Drug Application
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 15 Jan 2010
FDA Extends Review Period for Tarceva Application for First-Line Maintenance Use in Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Jan 2010
Medline to Distribute Only FDA-Cleared System to Both Count and Locate Surgical Sponges Left in Patients
Devices Surgery Distribution
 HSMN NewsFeed - 13 Jan 2010
FDA Gives TCA Cellular Therapy Green Light to Proceed with First ALS Adult Stem Cell Trial Using Patient's Own Stem Cells
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 13 Jan 2010
Octapharma Receives Orphan Drug Exclusivity Approval for wilate(R) - A Replacement Therapy Developed Specifically for von Willebrand Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Jan 2010
Tianyin Pharmaceutical Co., Inc. Receives Chinese SFDA Approval for Ofloxacin and Fleroxacin
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 13 Jan 2010
Pathway Medical Technologies Receives FDA 510(k) Clearance for JETSTREAM G3 Atherectomy System
Devices Interventional FDA
 HSMN NewsFeed - 12 Jan 2010
Michelson Diagnostics VivoSight(TM) OCT Scanner Receives FDA 510(k) Clearance
Devices FDA
 HSMN NewsFeed - 11 Jan 2010
FDA Lifts Injunction on Manufacture and Sale of CareFusion Alaris(R) SE Pump
Devices FDA
 HSMN NewsFeed - 11 Jan 2010
Cerner Receives FDA Clearance for Medical Device Connectivity Solution
Devices Monitoring FDA
 HSMN NewsFeed - 11 Jan 2010
Mylan Confirms First-to-File Patent Challenge Relating to Sleep-Disorder Drug Nuvigil(R)
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 11 Jan 2010
MAP Pharmaceuticals Announces FDA will not Require a Second Pivotal Efficacy Study for LEVADEX(TM) NDA Submission
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 9 Jan 2010
FDA Approves ACTEMRA(R) (tocilizumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Jan 2010
Savient Provides Update on KRYSTEXXA(TM) BLA Resubmission Activities
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Jan 2010
WorldHeart Receives Unconditional BTT Study Approval From FDA for Levacor(TM) VAD
Devices Cardiology FDA
 HSMN NewsFeed - 8 Jan 2010
Watson Files FDA Application for Generic LoSeasonique(R)
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 8 Jan 2010
FDA Grants 510(k) Marketing Clearance for Cytori's PureGraft System; First & Only Device on Market for Aesthetic Body Contouring using Autologous Fat Grafts
Devices Regenerative Medicine FDA
 HSMN NewsFeed - 7 Jan 2010
Ondine Files PMA Submission for Periowave(TM) Photodisinfection System
Devices Dental FDA
 HSMN NewsFeed - 7 Jan 2010
Sopherion Therapeutics Receives FDA Fast Track Designation for Myocet in Metastatic Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Jan 2010
Cepheid Receives FDA Clearance for First Rapid and Accurate Surveillance Test for vanA the Resistance Gene Most Associated with Hospital-Acquired VRE Infections
Diagnostics FDA
 HSMN NewsFeed - 5 Jan 2010
Levia(R) for Personal Targeted Phototherapy(TM) Treatment of Psoriasis Receives FDA 510(k) Clearance
Devices Dermatology FDA
 HSMN NewsFeed - 4 Jan 2010
FDA Approves Addition of Sustained Overall Survival Benefit to Label for VELCADE(R) (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Jan 2010
Cepheid Receives FDA Emergency Use Authorization (EUA) for First 2009 H1N1 Influenza Assay for CLIA 'Moderate Complexity' Laboratories
Diagnostics FDA
 HSMN NewsFeed - 31 Dec 2009
Photocure Received Positive Response From FDA on the New Drug Application (NDA) for Hexvix(R) for Detection of Bladder Cancer
Biopharmaceuticals Diagnostics Oncology FDA
 HSMN NewsFeed - 30 Dec 2009
ZOLL Receives FDA Clearance to Market E Series Defibrillators with Carbon Monoxide Monitoring
Devices Monitoring FDA
 HSMN NewsFeed - 30 Dec 2009
Pfizer Provides U.S. Regulatory Update On Prevnar 13 Vaccine
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Dec 2009
Biodel Submits VIAject(R) New Drug Application to FDA for Treatment of Diabetes
Biopharmaceuticals Drug Delivery Endocrinology FDA
 HSMN NewsFeed - 30 Dec 2009
Vion Pharmaceuticals Announces FDA Conclusion
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Dec 2009
FDA Issues Complete Response Letter for Ceftobiprole
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Dec 2009
FDA Accepts NDA Filing for Retigabine
Biopharmaceuticals Neurology FDA
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