Tag: FDA advisory committee

FDA Approves Failed Alzheimerā€™s Drug

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The FDA approved Biogen's failed drug aducanumab, overriding the 10-0 recommendation of its own advisory committee. Three panel members resigned in protest.

After-the-fact Pharma Payments to FDA Advisers Spark Ethical Concerns

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From Science: "Brilinta fits a pattern of what might be called pay-later conflicts of interest, which have gone largely unnoticedā€”and entirely unpoliced. In examining...

Flibanserin’s ‘Effects’ Do Not Outweigh Harms, Review Finds

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Despite concerns about the risk to benefit ratio, the FDA approved flibanserin (Addyi) to treat low female sexual desire in August. In a new...