


Healthcare News Roundup: FDA
HSMN NewsFeed - 13 Aug 2008
DigiMatch(TM) ROBODOC(R) Surgical System Receives U.S. FDA 510(k) Marketing Clearance
DigiMatch(TM) ROBODOC(R) Surgical System Receives U.S. FDA 510(k) Marketing Clearance
HSMN NewsFeed - 12 Aug 2008
Stromedix Receives Orphan Drug Designation for STX-100 in Chronic Allograft Nephropathy
Stromedix Receives Orphan Drug Designation for STX-100 in Chronic Allograft Nephropathy
HSMN NewsFeed - 11 Aug 2008
U.S. Food and Drug Administration Approves Viread(R) for Chronic Hepatitis B in Adults
U.S. Food and Drug Administration Approves Viread(R) for Chronic Hepatitis B in Adults
HSMN NewsFeed - 11 Aug 2008
Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For KYNAPID(TM)
Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For KYNAPID(TM)
HSMN NewsFeed - 11 Aug 2008
HemCon Bandages Receive Expanded Indications for Antibacterial Barrier, Including MRSA
HemCon Bandages Receive Expanded Indications for Antibacterial Barrier, Including MRSA
HSMN NewsFeed - 8 Aug 2008
FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months
FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months
HSMN NewsFeed - 8 Aug 2008
Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation
Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation
HSMN NewsFeed - 5 Aug 2008
Bovie Medical Corporation Announces FDA Clearance for Sale and Marketing of Its MEG Laparoscopic Line
Bovie Medical Corporation Announces FDA Clearance for Sale and Marketing of Its MEG Laparoscopic Line
HSMN NewsFeed - 1 Aug 2008
EKR Therapeutics Receives Approval for Ready-to-Use Intravenous Bags of Cardene(R) I.V.
EKR Therapeutics Receives Approval for Ready-to-Use Intravenous Bags of Cardene(R) I.V.
HSMN NewsFeed - 31 Jul 2008
FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
HSMN NewsFeed - 31 Jul 2008
Tianyin Pharmaceutical Co., Inc. Receives Chinese SFDA Approval for Simvastatin Tablets
Tianyin Pharmaceutical Co., Inc. Receives Chinese SFDA Approval for Simvastatin Tablets
HSMN NewsFeed - 30 Jul 2008
Banner Pharmacaps Receives FDA Approval for Valproic Acid Delayed Release Softgel Capsules
Banner Pharmacaps Receives FDA Approval for Valproic Acid Delayed Release Softgel Capsules
HSMN NewsFeed - 29 Jul 2008
Barr Confirms Patent Challenge of Sensipar(R) Tablets, 30mg, 60mg and 90mg
Barr Confirms Patent Challenge of Sensipar(R) Tablets, 30mg, 60mg and 90mg
HSMN NewsFeed - 29 Jul 2008
Advaxis Incorporated Receives List of Questions from the U.S. Food and Drug Administration
Advaxis Incorporated Receives List of Questions from the U.S. Food and Drug Administration
HSMN NewsFeed - 28 Jul 2008
Mylan Launches First Generic Version of Antihypertensive Sular(R) ER in the United States
Mylan Launches First Generic Version of Antihypertensive Sular(R) ER in the United States
HSMN NewsFeed - 28 Jul 2008
FDA Issues Not Approvable Letter for Iloperidone to Vanda Pharmaceuticals
FDA Issues Not Approvable Letter for Iloperidone to Vanda Pharmaceuticals
HSMN NewsFeed - 28 Jul 2008
Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone
Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone
HSMN NewsFeed - 24 Jul 2008
FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months
FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months
HSMN NewsFeed - 24 Jul 2008
PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in General Surgery
PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in General Surgery
HSMN NewsFeed - 22 Jul 2008
Response Biomedical Receives US FDA Clearance for RAMP(R) NT-proBNP Test for Diagnosis of Heart Failure
Response Biomedical Receives US FDA Clearance for RAMP(R) NT-proBNP Test for Diagnosis of Heart Failure
HSMN NewsFeed - 21 Jul 2008
FDA Clears Osmetech's Warfarin Sensitivity Test and New eSensor(R) XT-8 Platform
FDA Clears Osmetech's Warfarin Sensitivity Test and New eSensor(R) XT-8 Platform
HSMN NewsFeed - 17 Jul 2008
Misonix Receives FDA Approval of Second Sonatherm(R) Soft Tissue Ablation System
Misonix Receives FDA Approval of Second Sonatherm(R) Soft Tissue Ablation System
HSMN NewsFeed - 14 Jul 2008
Micrus Endovascular Receives FDA Approval for Intracranial Stent Clinical Trial
Micrus Endovascular Receives FDA Approval for Intracranial Stent Clinical Trial
HSMN NewsFeed - 3 Jul 2008
Mylan Announces Tentative FDA Approval for Generic Version of Antibiotic Zyvox(R) Tablets
Mylan Announces Tentative FDA Approval for Generic Version of Antibiotic Zyvox(R) Tablets
HSMN NewsFeed - 2 Jul 2008
Visionsense Announces Food and Drug Administration (FDA) 510(k) Clearance for Neurosurgery
Visionsense Announces Food and Drug Administration (FDA) 510(k) Clearance for Neurosurgery
HSMN NewsFeed - 1 Jul 2008
FDA Grants Conditional Approval to Interventional Spine's PercuDyn(TM) System IDE Application
FDA Grants Conditional Approval to Interventional Spine's PercuDyn(TM) System IDE Application
HSMN NewsFeed - 30 Jun 2008
Acusphere Announces FDA Acceptance of Imagify(TM) NDA for Detection of Coronary Artery Disease
Acusphere Announces FDA Acceptance of Imagify(TM) NDA for Detection of Coronary Artery Disease
HSMN NewsFeed - 30 Jun 2008
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Elavil(R)
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Elavil(R)
HSMN NewsFeed - 30 Jun 2008
GlaxoSmithKline Responds to FDA on CERVARIX(R) and Plans to Submit Final Study Data for Approval
GlaxoSmithKline Responds to FDA on CERVARIX(R) and Plans to Submit Final Study Data for Approval
HSMN NewsFeed - 30 Jun 2008
Introgen Submits ADVEXIN(R) Regulatory Applications in the U.S. and Europe
Introgen Submits ADVEXIN(R) Regulatory Applications in the U.S. and Europe
HSMN NewsFeed - 30 Jun 2008
New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
HSMN NewsFeed - 27 Jun 2008
ARKRAY USA Receives FDA Clearance on GLUCOCARD(TM) 01 Blood Glucose Monitoring System
ARKRAY USA Receives FDA Clearance on GLUCOCARD(TM) 01 Blood Glucose Monitoring System
HSMN NewsFeed - 23 Jun 2008
NanoGuardian Client Receives FDA Approval for Its Nanoencryption Technology
NanoGuardian Client Receives FDA Approval for Its Nanoencryption Technology
