News

Korean Biotech Startup Targeting Alzheimer’s Treatment Raises $42 Million Round
Illimis Therapeutics’ Series B round was led by Korean venture capital firm DSC Investment. Seoul-based Illimis Therapeutics has raised 58 billion won ($42 million) to fund its research into ...
Fierce Pharma7d
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 ...
BioSpace4h
FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...
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 (LLY) Secures FDA Label Update for Alzheimer’s Disease Treatment
Eli Lilly and Company (NYSE:LLY) is one of Goldman Sachs’ top healthcare stock picks. On July 9, the company confirmed the ...
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 ...
PharmExec5d
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 ...
BioSpace5d
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 ...
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 ...
The Pharma Letter6d
New dosing approved for Lilly’s Kisunla in Alzheimer’s
The US Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for ...
Clinical Advisor4d
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 ...
Medical Dialogues6d
Eli Lilly gets USFDA okay for updated Kisunla label with new dosing in early symptomatic Alzheimer's disease
Indianapolis: Eli Lilly and Company has received approval from the U.S. Food and Drug Administration (FDA) for a label update ...