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FDA related Press Releases

Columbia Laboratories Transfers NDA for Progesterone Vaginal Gel 8% to Watson Pharmaceuticals

Posted February 13, 2012

LIVINGSTON, N.J. and PARSIPPANY, N.J., Feb.13, 2012 /PRNewswire/ -- Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced that Columbia has Read more...

Insmed Incorporated Provides Update on Clinical Program for ARIKACE®

Posted February 10, 2012

MONMOUTH JUNCTION, N.J., Feb. 10, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the Company is proceeding with a phase 2 clinical trial Read more...

FDA issues draft guidance on biosimilar product development

Posted February 10, 2012

FDA issues draft guidance on biosimilar product development Feb. 9, 2012 The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist Read more...

Ironwood Announces FDA Advisory Committee Meeting Will Not Be Scheduled in Connection with New Drug Application for Linacl

Posted February 8, 2012

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that it was informed this evening that the U.S. Food and Drug Administration (FDA) will not schedule an Read more...

Neuralstem President and CEO to Present at BIO CEO & Investor Conference 2012

Posted February 8, 2012

Live Webcast to Air on Monday, February 13, at 3:00 p.m. ESTROCKVILLE, Md., Feb. 8, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announces that President and CEO Richard Garr will present Read more...

Medtronic Stent Resulted in 90% Freedom from Reinterventions in Narrowed Leg Arteries at 12 Months in International Study

Posted February 8, 2012

New Clinical Data Presented for First Time at Medical Meetings in U.S. and Europe Show Durable Vessel Patency in Treating Atherosclerotic Lesions of Superficial Femoral Artery MINNEAPOLIS--(BUSINESS Read more...

Idenix Announces Removal of the Partial Clinical Hold on HCV Nucleotide Inhibitor, IDX184

Posted February 3, 2012

CAMBRIDGE, Mass., Feb. 3, 2012 /PRNewswire/ -- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human Read more...

OptiNose Files Investigational New Drug Application to use Sumatriptan Delivered with its Novel Drug Delivery Technology

Posted February 2, 2012

YARDLEY, Pa.--(BUSINESS WIRE)-- OptiNose Inc. announces the filing of an Investigational New Drug (IND) with the U.S. Food and Drug Administration (FDA) in December, 2011. The FDA has completed its Read more...

Mylan Receives Tentative FDA Approval for Generic Version of Lipitor®

Posted February 2, 2012

PITTSBURGH, Feb. 2, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval Read more...

BIO Testifies on Importance of Prompt Enactment of PDUFA V Recommendations

Posted February 1, 2012

Encourages Reauthorization of BPCA and PREA WASHINGTON--(BUSINESS WIRE)-- Richard Pops, Chairman and CEO of Alkermes plc, testified today on behalf of the Biotechnology Industry Organization (BIO) Read more...