"FDA Delays Review of Eli Lilly's Alzheimer's Drug Donanemab"
TL;DR Summary
The FDA has delayed the approval of Eli Lilly's proposed Alzheimer's drug, donanemab, for further review, surprising the company and causing a slight drop in its stock price. The FDA will hold an advisory committee meeting to scrutinize the drug's safety and effectiveness, which targets the amyloid beta substance in the brain linked to Alzheimer's disease. While clinical trials have shown that donanemab slows cognitive decline in early-stage Alzheimer's patients, the drug's logistical constraints and the divisive nature of amyloid-targeting drugs have raised concerns within the medical community.
- 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
- F.D.A. Delays Action on Closely Watched Alzheimer's Drug The New York Times
- Eli Lilly's donanemab Alzheimer's drug delayed by FDA USA TODAY
- Eli Lilly Alzheimer's Drug Delayed as FDA Plans Advisory Panel Meeting The Wall Street Journal
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