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

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 ...

A European regulatory committee has rejected Eli Lilly's U.S.-approved Alzheimer's disease treatment over potentially ...

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

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

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

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

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

Sleep deficiency was associated with atrophy of the inferior parietal region, which is observed in early Alzheimer's disease. (Journal of Clinical Sleep Medicine) Researchers assessed evidence ...