Some neurologists and a consumer watchdog worry that an Eli Lilly–affiliated direct-to-consumer telehealth platform for Alzheimer’s could lead to misdiagnosis or unnecessary treatment.

The European Medicines Agency’s Committee for Medicinal Products for Human Use issued an opinion that does not recommend Eli Lilly (LLY) and Company’s donanemab be granted marketing ...

An expert panel of the EU drug regulator, the European Medicines Agency (EMA), on Friday declined to endorse Kisunla (donanemab), Eli Lilly’s (NYSE:LLY) candidate for early Alzheimer’s disease ...

The risk for amyloid-related imaging abnormalities in early-stage Alzheimer’s disease is primarily driven by the ...

The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, delaying its review of ...

The EMA committee said Eli Lilly proposed restricting donanemab’s approval to people who do not have this gene. But it said the benefits still did not outweigh the risks for this group.

Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer's disease therapy donanemab based on mid-stage clinical results, but says it remains on track to file ...

After failing to pass muster with England’s drug reimbursement watchdog earlier this month, Eli Lilly’s Alzheimer’s disease med Kisunla (donanemab) also got a rejection from EU regulators.