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GlaxoSmithKline says its darapladib failed to meet the primary endpoint in a Phase 3 trial of its use in adults with chronic coron...[ Price : $8.95]
Nautilus asks FDA to reconsider its request for a deferral of pediatric studies of its migraine analgesic Cambia.[ Price : $8.95]
FDA tells Sarepta Therapeutics that its planned NDA filing is premature for eteplirsen and its use in treating Duchenne muscular d...[ Price : $8.95]
FDA clears an IntelligentMDx 510(k) for its IMDx C. difficile for use with Abbotts m2000 assay.[ Price : $8.95]
FDA commissioner Margaret Hamburg says her agency is working with Mekong Region counterparts on issues of food and drug safety.[ Price : $8.95]
CBER says its online submission system was compromised 10/15 and user information was obtained by the unidentified hacker.[ Price : $8.95]
FDA releases results of its survey of 11 surgeons on their experiences using the da Vinci Surgical System.[ Price : $8.95]
FDA approves a Discovery Laboratories IND for Aerosurf, allowing the company to launch a Phase 2 clinical trial program.