FDA Approves Label Change for Alzheimer's Amyloid Drug

FDA Approves Label Change for Alzheimer's Amyloid Drug

Brain edema risk expected to be less with new donanemab dosing schedule

Eli Lilly wins FDA label update for Alzheimer's drug (LLY:NYSE)

Donanemab-Azbt Receives FDA Label Update With New Dosing for Alzheimer Disease

FDA approves a new dosing schedule for donanemab, enhancing safety and efficacy in treating early symptomatic Alzheimer disease.

Atsena Announces Alignment with FDA on Regulatory Pathway to Approval for ATSN-201 in X-Linked Retinoschisis (XLRS)

Atsena Therapeutics announced that the FDA has agreed to the expansion of the company’s ongoing phase 1/2 LIGHTHOUSE study of ATSN-201 into a continuous phase 1/2/3 trial, enabling it to serve as a pivotal trial to support a Biologics License Application (BLA) submission for the treatment of X-linked retinoschisis (XLRS). The BLA submission is anticipated in early 2028. “This regulatory milestone marks another significant step toward delivering …

FDA approves new dosing of Lilly’s Alzheimer’s drug to lower brain swelling risks

Eli Lilly’s new Alzheimer’s drug is off to a slow start, but the Indianapolis drugmaker hopes that an update to the treatment’s prescription label may help build confidence among doctors and patients ...