Tag: FDA advisory committee
FDA Approves Failed Alzheimerās Drug
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
From Science: "Brilinta fits a pattern of what might be called pay-later conflicts of interest, which have gone largely unnoticedāand entirely unpoliced. In examining...
Flibanserin’s ‘Effects’ Do Not Outweigh Harms, Review Finds
Despite concerns about the risk to benefit ratio, the FDA approved flibanserin (Addyi) to treat low female sexual desire in August. In a new...