Despite shaky evidence and reviewer differences, the US Food and Drug Administration swiftly approved Aduhelm from Biogen, Exondys 51 (eteplirsen) from Sarepta, and Makena from Covis Pharma, the Department of Health and Human Services’ Office of Inspector General reported Tuesday. The analysis discovered that in one instance, there was no documentation about important choices.
3 Drugs Receiving Accelerated Approval from the FDA and Reviewed by the Office of Inspector General Raised Concerns
