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FDA Approves Donanemab for Early Symptomatic Alzheimer Disease: Daily Dose / image credit: ©New Africa/AdobeStock
FDA Approves Donanemab for Early Symptomatic Alzheimer Disease: Daily Dose

July 10th 2024

Your daily dose of the clinical news you may have missed.

©Lilly's Donanemab Approved by FDA for Treatment of Early Symptomatic AD / image credit fda approval stamp: waldenmarus/stock.adobe.com
Lilly's Donanemab Approved by FDA for Treatment of Early Symptomatic AD

July 2nd 2024

Eisai Files sBLA for Lecanemab-irmb Maintenance Dose, Reports Delay on SC Formulation / image credit Alzheimer disease concept: ©Zerbor/stock.adobe.com
UPDATE 6-11-2024: Eisai Files sBLA for Lecanemab-irmb Maintenance Dosing

June 11th 2024

Donanemab FDA AdComm Hearing Scheduled for June 10, Eli Lilly Says
Donanemab FDA AdComm Hearing Scheduled for June 10, Eli Lilly Says

May 8th 2024

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

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