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

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

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

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 ...

Weight loss drugs such as semaglutide, found in Ozempic and Wegovy, are tied to a 40% reduced risk of an Alzheimer's disease diagnosis. On Wednesday, a study in Nature suggested that a vaccine for ...

The pandemic showed just what can be achieved with faster and more efficient regulatory approval — the same approach needs to be applied now to save patients’ lives and tackle the growing burden ...

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

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

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