The Department of Health and Human Services (HHS) Office of the Inspector General will review the FDA’s accelerated approval pathway, the office announced Wednesday. This sweeping review comes just two months after the controversial approval of Biogen’s Alzheimer’s drug Aduhelm. The review will focus on the FDA’s accelerated approval pathway — a route that allows […]
Maker of dubious $56K Alzheimer’s drug offers cognitive test no one can pass
After facing intense criticism, Biogen goes on defense, blames “misinformation.”