The benefit-risk balance is tipping more in favor of Eli Lilly’s Kisunla in early Alzheimer’s disease as the FDA ...

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

The Food and Drug Administration (FDA) has updated the labeling for Kisunla ™ (donanemab-azbt) to include a new recommended titration dosing schedule for adults with early symptomatic Alzheimer ...

Approval was based on results from the Phase IIIb TRAILBLAZER-ALZ 6 trial, which showed that Kisunla achieved comparable ...

Lilly's Kisunla gets FDA approval for a new dosing schedule that significantly lowers ARIA-E risk while maintaining amyloid ...

FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease Jul. 09, 2025 6:45 AM ET Eli Lilly and Company (LLY) ...

FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease Provided by PR Newswire Jul 9, 2025, 10:45:00 AM ...

The U.S. Food and Drug Administration approved changing the prescribing information for Eli Lilly's Alzheimer's drug Kisunla to allow more gradual dosing to lower the risk of a potentially dangerous ...

Eli Lilly has won a green light from the FDA for new dosing for its Alzheimer's disease therapy Kisunla, which carries a ...

The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding to the established safety profile of the treatment INDIANAPOLIS, ...