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

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

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 ...

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

A key result of a workshop series of European regulatory authorities and HTA agencies: Drug studies should be designed in such a way that they address both regulatory questions and the essential ...

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

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

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shared an update on Elevidys (delandistrogene moxeparvovec-rokl), the only approved ...

The European Medicines Agency committee said the benefits of the new drug, Kisunla, did not outweigh the risks, and it recommended refusing marketing authorization for it. The agency’s Committee ...