The EMA’s Committee for Medicinal Products for Human Use said that a phase 3 study in children aged 3-14 years demonstrated ...

The EMA has recommended refusing marketing authorization for donanemab, a monoclonal antibody against amyloid beta, in the ...

The European Medicines Agency’s (EMA’) human medicines committee (CHMP) has recommended two new medicines and three ...

The European Medicines Agency has rejected Lilly’s Alzheimer’s drug Kisunla for a license, saying its benefits don’t outweigh ...

Shanghai Henlius Biotech and Organon (OGN) announced that the European Medicines Agency has validated the marketing authorization application ...

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

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

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

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 it shouldn't be approved.

The EU’s medicines regulator has declined to approve Eli Lilly’s new Alzheimer’s drug, deciding the risks of serious and potentially fatal side effects outweigh the benefits of slowing progression of ...

Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications ...