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FDA Cites Daiichi Sankyo Over Mailer to Physicians

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A just-post FDA untitled letter cites Daiichi Sankyo for making misleading claims in a mailer to health professionals for hyperten...

Aegerion Pharma CEO Cited for Statements on CNBC

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FDA objects to statements made by Aegerion Pharmaceuticals CEO Marc Beer on CNBCs Fast Money program that it says broadened the in...

Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that several drug products were not withdrawn from sale for reasons of safety or effective...

Erytech Pharma Gets OK from Monitoring Board for Leukemia Drug

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Erytech Pharma says an independent Data and Safety Monitoring Board completed its first assessment of a Phase 2b study evaluating ...

Study Backs Pediatric Cough Cold Medicine Re-Labeling

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A Centers for Disease Control and Prevention study says emergency department visits associated with OTC pediatric cough cold medic...

Panel to Discuss BMS NDA for Diabetes

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 12/12 to discuss a Bristol-Myers Squ...

Panel to Vote on Cardiac Implant

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 12/11 to vote on a Boston Scientific PMA for the WATCHMAN...

Pfizer Rapamune Study Misses Primary End Point

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A Phase 3B/4 study involving Pfizers Rapamune in kidney transplant patients who transitioned from tacrolimus-based therapy (TAC) t...

Fast Track Status for Alnylam Pharmas Patisiran

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FDA grants Alnylam Pharmaceuticals a fast track designation for ALN-TTR02 (patisiran) for treating transthyretin-familial amyloid ...

FTC Workshop to Examine Biosimilar Naming Issues

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The Federal Trade Commission hosts a workshop to examine competition issues surrounding biologic and follow-on biologic medication...