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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 ...
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 ...
Clinical Advisor7h
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 ...
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 ...
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 ...
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 ...
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 ...
Fierce Biotech7h
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 ...
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 ...
Eli Lilly (NYSE:LLY) Gains FDA Approval For New Alzheimer's Drug Dosing Schedule
Eli Lilly (NYSE:LLY) recently received FDA approval for a new dosing schedule of Kisunla, aimed at reducing amyloid-related ...
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 ...