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GSK Darapladib Trial Fails to Meet Endpoint

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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...

Nautilus Asks Cambia PREA Deferral Reconsideration

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Nautilus asks FDA to reconsider its request for a deferral of pediatric studies of its migraine analgesic Cambia.

FDA Says Sarepta NDA for Eteplirsen is Premature

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FDA tells Sarepta Therapeutics that its planned NDA filing is premature for eteplirsen and its use in treating Duchenne muscular d...

FDA Clears IntelligentMDx C. difficile Assay

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FDA clears an IntelligentMDx 510(k) for its IMDx C. difficile for use with Abbotts m2000 assay.

FDA Partnering with Mekong Region on Food, Drug Safety

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FDA commissioner Margaret Hamburg says her agency is working with Mekong Region counterparts on issues of food and drug safety.

CBER Submissions System Hacked and IDs Stolen

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CBER says its online submission system was compromised 10/15 and user information was obtained by the unidentified hacker.

FDA Releases Survey on da Vinci System Experiences

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FDA releases results of its survey of 11 surgeons on their experiences using the da Vinci Surgical System.

Discovery Labs to Start Aerosurf Phase 2 Trial

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FDA approves a Discovery Laboratories IND for Aerosurf, allowing the company to launch a Phase 2 clinical trial program.

FDA Releases Burzynski Research Institute FDA-483

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FDA releases an FDA-483 from an inspection at Burzynski Research Institute.

FDA Gives Medicines Co. QIDP Designation for Antibiotic

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FDA gives the Medicines Co. a Qualified Infectious Disease Product designation for oritavancin and its use in treating acute bacte...