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FDA’s Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
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Eli Lilly's Kisunla wins FDA nod for new dosing with fewer side effects in Alzheimer's
The benefit-risk balance is tipping more in favor of Eli Lilly’s Kisunla in early Alzheimer’s disease as the FDA ...
PharmExec23h
FDA Approves Label Update for Eli Lilly’s Kisunla to Reduce ARIA-E Risk in Early Alzheimer Disease Treatment
Approval was based on results from the Phase IIIb TRAILBLAZER-ALZ 6 trial, which showed that Kisunla achieved comparable ...
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Eli Lilly’s Alzheimer’s Drug Gets US FDA Label Update For More Gradual Dosing After Study Shows Reduced Side Effects
Eli Lilly and Company (LLY) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved a label ...
FDA Approves New Dosing Schedule For Eli Lilly's Kisunla In Alzheimer's Treatment
Lilly's Kisunla gets FDA approval for a new dosing schedule that significantly lowers ARIA-E risk while maintaining amyloid ...
BioPharma Dive2d
Lilly gets FDA OK of modified dosing for Alzheimer’s drug
A slower ramp-up of Kisunla dosing lowers the rate of dangerous brain swelling, a risk that has made doctors reluctant to ...
US FDA approves gradual dosing for Lilly Alzheimer's drug
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 ...
pharmaphorum2d
FDA clears new, safer regimen for Lilly's Alzheimer's drug
Eli Lilly has won a green light from the FDA for new dosing for its Alzheimer's disease therapy Kisunla, which carries a ...
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FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with ...
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) ...
BioSpace2d
Lilly Gets FDA Label Update for Alzheimer’s Drug To Mitigate Safety Concerns
The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of ...
Morningstar2d
FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with ...
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 ...