The European Commission approved Pfizer's respiratory syncytial virus vaccine for the prevention of lower respiratory tract ...

CHMP recommends approval for XOANACYL, an oral therapy for use in the following therapeutic areas: Iron deficiency, chronic renal failure and ...

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 ...

Substandard and fake medicines remain a major threat in Africa, risking lives and fuelling drug resistance. A unified ...

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

Eli Lilly's Alzheimer's treatment is approved for use in the U.S. but the European Medicines Agency recommended against the ...

The European Medicines Agency (EMA) announced it is exploring improvements to the development and evaluation of biosimilar ...

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

The benefits of naltrexone/bupropion (Mysimba) continue to outweigh its risks, despite ongoing uncertainty about long-term ...

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

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

In response to a request from the European Medicines Agency (EMA) following the death of a 16-year-old patient in the U.S., ...