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BioSpace2d
FDA 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 ...
Recent findings in Alzheimer’s research indicate progress
Saturday at the Dream Center, the Bismarck Memory Cafe hosted a presentation from the Alzheimer’s Association about recent ...
Fierce Pharma4d
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 ...
PharmExec3d
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 ...
MPR2d
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 ...
Cognition soars 35% after positive FDA meeting on Alzheimer's asset zervimesine
Microcap Cognition Therapeutics (NASDAQ:CGTX) has skyrocketed 35% in Thursday trading after stating the company had a ...
Stocktwits on MSN4d
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 Dive4d
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 ...
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 ...
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 ...
clinicaladvisor.com3d
FDA Approves New Dosing Regimen for Kisunla in Alzheimer Disease
References: FDA approves updated label for Lilly’s Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer’s disease. News release. Eli Lilly and Company.