AANP SmartBrief Latest Industry Press Releases

Press Releases

FDA Extends Review of NDA for Exalgo

Business Wire | 3 days 7 hours 40 minutes ago

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has set a new action date under the Prescription Drug User Fee Act for the review of the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl extended-release) Tablets (CII), (Exalgo) of February 22, 2010.... (more)

FDA Extends NDA Review for Exalgo Extended-Release Tablets

Business Wire | 3 days 7 hours 41 minutes ago

CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months. The extended Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of the Exalgo NDA has been set for Febru...... (more)

SILENCE THERAPEUTICS PLC - Notice of AGM

PRNewswire | 3 days 13 hours 11 minutes ago

Silence Therapeutics plc Notice of Annual General Meeting ... (more)

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