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

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

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

GSK plc GSK announced that the European Medicines Agency (“EMA”) has accepted for review a regulatory filing, seeking ...

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the ...

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

GSK’s application is underpinned by the positive outcomes from the Phase III MATINEE trial, which demonstrated a significant ...

The EU's pharma legislation wants to turn paper leaflets in medication packaging into QR codes — driven by Big Pharma influence — but patients argue this change creates unnecessary confusion, ...

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

Crinetics (CRNX) announced that the European Medicines Agency has validated the marketing authorization application for paltusotine, the first ...

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11 ...