Tag: FDA advisory committee
Depression Drug Approved by FDA Had 11 Failed Trials and an...
Rejected by the FDA four times; an advisory committee vote against approval. Yet in 2023, gepirone (Exxua) was approved for depression.
FDA Approves Failed Alzheimer’s 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 unnoticed—and 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...
