FDA Delays Decision on Eli Lilly's Alzheimer's Drug, Donanemab
TL;DR Summary
The FDA has delayed its decision on Eli Lilly's Alzheimer's drug, donanemab, seeking input from its advisory committee to better understand the drug's safety and effectiveness. If approved, it would have been the third drug in a new class aimed at slowing Alzheimer's progression. Concerns about potential side effects and controversies surrounding similar drugs, such as Biogen's Aduhelm, have put the FDA under scrutiny.
- In an unusual move, FDA postpones approval decision for Lilly’s Alzheimer’s drug NBC News
- F.D.A. Delays Action on Closely Watched Alzheimer's Drug The New York Times
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- FDA will conduct more review of Eli Lilly's Alzheimer's drug donanemab - The Washington Post The Washington Post
- U.S. Food and Drug Administration to Convene Advisory Committee Meeting to Discuss the TRAILBLAZER-ALZ 2 Study of Donanemab | Eli Lilly and Company Investors | Eli Lilly and Company
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