Lilly said it is planning to request a re-examination of the CHMP's appraisal of Kisunla, pointing out that the drug has ...

The European Union’s CHMP said that the benefits of the drug, already approved in the U.S., do not outweigh the risk of ...

After failing to pass muster with England’s drug reimbursement watchdog earlier this month, Eli Lilly’s Alzheimer’s disease ...

Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal ...

Biopharma leaders react to the forced resignation of CBER Head Peter Marks as RFK Jr.’s promised job cuts begin at the FDA; ...

Despite further analyses in a subgroup of patients with no copies of the ApoE4 gene, known to have a lower risk of ARIA, the ...

Eli Lilly's Kisunla was approved in the U.S. for Alzheimer's last year, but now advisers to the European Medicines Agency say ...

Eli Lilly, which is seeking European approval of Kisunla for the treatment of early symptomatic Alzheimer's, said it will seek re-examination by CHMP. The Indianapolis drugmaker said it remains ...

The European Medicines Agency committee said the benefits of the new drug, Kisunla, did not outweigh the risks, and it ...

Lilly will seek review of decision which said drug's benefits don’t outweigh risk of potentially fatal bleeding in the brain ...

The EU medicines regulator on Friday rejected Eli Lilly's Alzheimer's drug, saying the treatment's ability to slow cognitive ...