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BioSpace16h
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 ...
Clinical Advisor13h
FDA Approves New Dosing Regimen for Kisunla in Alzheimer Disease
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 ...
Fierce Pharma2d
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 ...
PharmExec1d
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 ...
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 ...
Fierce Biotech12h
Quest Diagnostics to carry Fujirebio’s FDA-cleared Alzheimer’s blood test
Quest Diagnostics has signed up to offer a blood test that can help diagnose Alzheimer’s disease, following its FDA clearance ...
FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label ...
MedPage Today on MSN3d
FDA Approves Label Change for Alzheimer's Amyloid Drug
Donanemab was approved by the FDA in July 2024 to treat adults with early symptomatic Alzheimer's disease with confirmed ...
Stocktwits on MSN2d
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 ...
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 ...
Becker's Hospital Review1d
FDA OKs label change for Alzheimer’s drug
The FDA has approved a label update for Eli Lilly’s Kisunla, an Alzheimer’s treatment, by modifying the recommended dosing schedule for adults with early symptomatic Alzheimer’s disease. The update ...