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Eli Lilly has announced that the US Food and Drug Administration's (FDA)  Peripheral and Central Nervous System Drugs Committee will convene for a meeting to deliberate over its antiamyloid therapy donanemab, and the supportive phase 3 TRAILBLAZER-ALZ 2 trial (NCT04437511).1 The date of the advisory meeting has yet to be set by the FDA, and, as a result, the timing of expected FDA action for the treatment will be delayed beyond the first quarter of 2024.1
Lilly Investigational Alzheimer Agent Donanemab Phase 3 Findings Under FDA Review

March 8th 2024

The surprise request for review of the phase 3 TRAILBLAZER-ALZ-2 clinical trial findings will delay the original PDUFA timing beyond first quarter 2024.

/ image credit Amyloid plaque: ©Artur/stock.adobe.com
Plasma Immunoassay for Alzheimer Disease Found Highly Accurate and is Commercially Available

February 29th 2024

Fact vs fiction in Alzheimer disease image credit ©Billion Photos/shutterstock.com
Fact vs Fiction in Alzheimer Disease

November 13th 2023

New Data on Alzheimer Disease Research from Biogen Planned for CTAD 2023 Meeting  / image credit ©Zerbor/stock.adobe.com
New Data on Alzheimer Disease Research from Biogen Planned for Release at CTAD 2023 Meeting

October 20th 2023

Incorporating Blood-Based Biomarkers Advances Approach to Diagnosing Alzheimer Disease
Incorporating Blood-Based Biomarkers Advances Approach to Diagnosing Alzheimer Disease

July 28th 2023

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