The oral COVID-19 drug is the second to produce promising trial results.
Aduhelm approval sparks HHS watchdog review of FDA’s accelerated approval pathway
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 […]