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Eli Lilly's Alzheimer’s Drug Donanemab Fails to Get Early FDA Approval

Por: Time Health January 20, 2023

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Eli Lilly & Co.’s bid for accelerated approval of its Alzheimer’s therapy was rejected by U.S. regulators, an unexpected setback for the drugmaker. The Food and Drug Administration sent the company a complete response letter saying it would not give the early approval for the drug because not enough patients on the trial had received it for a full 12 months, Lilly said Thursday in a statement. The agency wanted Lilly to provide safety data... + full article



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