FDA related Press Releases
Columbia Laboratories Transfers NDA for Progesterone Vaginal Gel 8% to Watson Pharmaceuticals
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®
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FDA issues draft guidance on biosimilar product development
FDA issues draft guidance on biosimilar product development Feb. 9, 2012 The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist Read more...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
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
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
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
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
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®
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
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...
Paid Research Reports
- Trends in mHealth and Telemedicine
- The Global Aesthetic Dermatology Market Outlook
- Future Directions in Regenerative Medicine
- Pipeline Insight: Insulin Antidiabetics – Novel analogs show promise as alternative delivery methods prove less attractive
- Pipeline Insight: Non-insulin Antidiabetics - Rise of the weight-reducers: Once-weekly GLP-1 agonists and novel SGLT-2 inhibitor
- Forecast Insight: Antidiabetics - Diabetes market growth driven by epidemiological trends and rich pipeline
