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Healthcare News Roundup: FDA

 HSMN NewsFeed - 24 Jan 2011
Mylan's Matrix Receives Approval for Generic Version of Protonix(R) Delayed-release Tablets
Biopharmaceuticals Generics Gastroenterology FDA
 HSMN NewsFeed - 24 Jan 2011
Furiex Receives FDA Fast Track Designation of MuDelta for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 24 Jan 2011
Clinical Data, Inc. Announces FDA Approval of Viibryd(TM) (vilazodone HCl) for Major Depressive Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jan 2011
VIVUS Provides Regulatory Update on QNEXA NDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jan 2011
On-X LTI Receives FDA Approval for Aortic Valve with Vascutek Graft
Devices Cardiology FDA
 HSMN NewsFeed - 20 Jan 2011
Spectranetics Receives FDA Approval for Site Change Related to Manufacturing of CVX-300(R) Laser System
Devices FDA
 HSMN NewsFeed - 19 Jan 2011
Andrew von Eschenbach, M.D., Former FDA Commissioner and Leading Prostate Cancer Expert, Elected to Viamet Pharmaceuticals Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 18 Jan 2011
Cook Medical Receives FDA Approval for Two Renal Stents
Devices Interventional FDA
 HSMN NewsFeed - 17 Jan 2011
AdvanDx Receives FDA 510(k) Clearance for GNR Traffic Light(TM) PNA FISH(R)
Diagnostics Personalized Medicine FDA
 HSMN NewsFeed - 13 Jan 2011
Nanosphere Receives FDA Clearance for Respiratory Virus Subtyping Test Panel
Diagnostics FDA
 HSMN NewsFeed - 13 Jan 2011
Given Imaging's Bravo(R) pH Monitoring System Cleared for Use in Children
Devices Monitoring FDA
 HSMN NewsFeed - 11 Jan 2011
Wright Medical Group, Inc. Announces IDE Approval for Calcaneal Stem Fixation for the INBONE(R) Total Ankle System
Devices Orthopaedic FDA
 HSMN NewsFeed - 10 Jan 2011
Varian Medical Systems Receives 510(k) Clearance for its Proton Therapy System
Devices Oncology FDA
 HSMN NewsFeed - 10 Jan 2011
Exelixis’ XL184 Granted Orphan Drug Designation and Assigned the Generic Name Cabozantinib
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Jan 2011
Orexo: FDA Approval For Abstral (Fentanyl) Sublingual Tablets - US Launch Planned For Q1 2011
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Jan 2011
Stellar Pharmaceuticals Annouces the Approval of Uracyst(R) by the KFDA in South Korea
Biopharmaceuticals Urology Regulatory
 HSMN NewsFeed - 5 Jan 2011
FDA Grants Supplemental Approval for ACTEMRA(R) (tocilizumab)
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Jan 2011
FDA Extends Marketing Exclusivity for INOMAX(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Jan 2011
U.S. Food and Drug Administration (FDA) Clears Novel ImageSense(TM) Technology for Use with Colposcopy
Devices Oncology FDA
 HSMN NewsFeed - 4 Jan 2011
Gore Receives FDA Approval for Innovative GORE(R) C3 Delivery System for GORE(R) EXCLUDER(R) AAA Endoprosthesis
Devices Interventional FDA
 HSMN NewsFeed - 28 Dec 2010
Pharming and Santarus announce submission of Rhucin Biologics License Application to FDA
Biopharmaceuticals
 HSMN NewsFeed - 27 Dec 2010
Cephalon Receives Complete Response Letter for NUVIGIL for the Treatment of Excessive Sleepiness Associated With Jet Lag Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Dec 2010
Swedish Orphan Biovitrum's Long-Lasting Hemophilia A Therapy Receives Orphan Drug Designation in the US
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Dec 2010
US FDA Approves New Indication for Merck's HPV Vaccine, GARDASIL(R)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Dec 2010
Delcath Completes New Drug Application Submission to the FDA for the Chemosaturation Delivery System
Biopharmaceuticals Devices Drug Delivery Oncology FDA
 HSMN NewsFeed - 22 Dec 2010
FDA Issues Complete Response Letter Regarding Acetadote(R) Supplemental New Drug Application for Acute Liver Failure
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Dec 2010
Medtronic Receives FDA Approval for First and Only Cryoballoon Ablation Treatment in the U.S. for Paroxysmal Atrial Fibrillation
Devices Cardiology FDA
 HSMN NewsFeed - 15 Dec 2010
Accuray Receives FDA Clearance for the CyberKnife(R) System's Lung Optimized Treatment
Devices Oncology FDA
 HSMN NewsFeed - 15 Dec 2010
Zephyr's Remote Physiological Monitoring Solution Receives FDA Approval
Devices Monitoring FDA
 HSMN NewsFeed - 14 Dec 2010
FDA Grants Hemispherx Biopharma Extension in Its Pending NDA for Treatment of Chronic Fatigue Syndrome (CFS)
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Dec 2010
Medtronic Launches CareLink Pro 3.0, the First Diabetes Management Software to Offer Advanced Decision Support
Devices Endocrinology FDA
 HSMN NewsFeed - 13 Dec 2010
Clear Catheter Systems Receives US FDA Clearance for the PleuraFlow Active Tube Clearance System
Devices FDA
 HSMN NewsFeed - 10 Dec 2010
Tomophase OCTIS(TM) Receives FDA 510(K) Clearance to Market
Devices FDA
 HSMN NewsFeed - 8 Dec 2010
Prodesse ProAdeno+ Assay Cleared for US Marketing by FDA
Diagnostics FDA
 HSMN NewsFeed - 8 Dec 2010
Bavarian Nordic Receives Special Protocol Assessment Agreement From the FDA for Phase 3 Trial of PROSTVAC(R)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Dec 2010
Orexigen(R) Therapeutics' Investigational Drug Contrave(R) Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Dec 2010
Orthovita Receives FDA Clearance for Vitoss(TM) Bioactive Foam-2X Bone Graft Substitute
Devices Orthopaedic FDA
 HSMN NewsFeed - 6 Dec 2010
NeuroVive Obtains U.S. Orphan Drug Designation for Traumatic Brain Injury
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 3 Dec 2010
CONMED Corporation Receives Clearance From FDA for Novel Tissue Fusion System
Devices Surgery FDA
 HSMN NewsFeed - 3 Dec 2010
Oceana Therapeutics Announces FDA Advisory Committee Recommends Approval of Solesta(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Dec 2010
Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 2 Dec 2010
US FDA Advisory Committee Makes Recommendation on New Drug Application for Vandetanib in Advanced Medullary Thyroid Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Dec 2010
Sagent Pharmaceuticals Announces FDA Approval of Midazolam Injection, USP
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Dec 2010
MedPro Safety Products Receives FDA Market Clearance for Passive Safety Winged Blood Collection Set
Devices FDA
 HSMN NewsFeed - 2 Dec 2010
Medtronic Announces CD HORIZON(R) System 510k Pedicle Screw Clearance for Adolescent Idiopathic Scoliosis
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 2 Dec 2010
FDA Accepts Guided Therapeutics' Non-Invasive Cervical Cancer Scanner PMA Application for Review
Devices Diagnostics Oncology FDA
 HSMN NewsFeed - 2 Dec 2010
Abiomed Receives Conditional FDA Approval for Study with Impella 2.5 in Reducing Heart Muscle Damage Following PCI in STEMI Patients
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 2 Dec 2010
Tryton Announces Investigational Device Exemption Conditional Approval from FDA to Conduct U.S. Pivotal Study of Side Branch Stent
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 2 Dec 2010
Covidien Receives FDA 510(k) Clearance for the iDrive(TM) Powered Stapling System
Devices Surgery FDA
 HSMN NewsFeed - 1 Dec 2010
Cubist Pharmaceuticals Receives FDA Approval for 2-Minute IV Injection of CUBICIN
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Dec 2010
Octapharma USA Focuses on Urgent Surgeries as FDA Approves octaplex(R) for Fast Track Development
Biopharmaceuticals Surgery FDA
 HSMN NewsFeed - 30 Nov 2010
X-spine Announces New FDA Product Clearance
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 30 Nov 2010
Inspire Medical Systems Announces FDA approval for Pivotal Clinical Trial
Devices Neurology FDA
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