PP_1170x120_10-25-21

Aduhelm

FDA head seeks probe of Aduhelm approval

FDA head seeks probe of Aduhelm approval

WASHINGTON _  Acting Food and Drug Administration commissioner Janet Woodcock on Friday sought a federal probe into the agency’s approval last month of Biogen Inc.’s controversial Alzheimer’s disease drug Aduhelm. In a letter to the Office of Inspector General, Woodcock requested that the independent watchdog investigate the interactions between the drugmaker and the FDA  during

FDA narrows indication for Aduhelm

FDA narrows indication for Aduhelm

SILVER SPRING, Md. _ The Food and Drug Administration has narrowed the indication for Biogen and Eisai Co.’s controversial Alzheimer’s disease drug Aduhelm (aducanumab-avwa), recommending it only for patients with mild symptoms. The FDA approved an updated label to align it with the disease stages studied in clinical trials. Approved wording includes, “Treatment with Aduhelm