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

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

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

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.

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

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended against marketing authorization for Eli Llilly's Alzheimer's drug Kisunla ...

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

The European Medicines Agency (EMA) has agreed to review GSK’s application of expanding Nucala’s (mepolizumab) use as add-on ...

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

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

The psoriasis market is estimated at $30 Billion by 2030 and has shifted significantly to oral drugs Ramat Gan, Israel, March ...

The European Medicines Agency (EMA) has agreed to review GSK’s application of expanding Nucala’s (mepolizumab) use as add-on maintenance for individuals with chronic obstructive pulmonary ...