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 ...

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

Mizuho says that while “any clinical hold is concerning,” the European Medicines Agency’s request to pause the three Elevidys studies will ...

Sarepta Therapeutics (SRPT) stock drops as the EU officials request a clinical hold on trials involving its gene therapy ...

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 ...

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

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

The European Medicines Agency will review GSK's request to approve its asthma drug Nucala as an additional treatment for ...

GSK on Monday said that the European Medicines Agency has agreed to review a request to approve the British drugmaker's ...

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

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