BeOne Medicines AG (NASDAQ:ONC) saw its stock rise 2.5% in pre-market trading after the European Medicines Agency (EMA) issued a favorable opinion on its cancer drug TEVIMBRA for early-stage lung ...

The European Medicines Agency has recommended authorizing a twice-yearly injectable drug to prevent HIV. LONDON (AP) — The ...

The European Medicines Agency (EMA) cleared the way for the use of another drug to treat Alzheimer's disease on Friday.

(Reuters) -Swiss drugmaker Roche Holding plans to investigate whether an experimental medicine can delay or prevent Alzheimer ...

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...

The European Union's drug regulator has recommended approval of Moderna's updated formulation of COVID-19 shot Spikevax, the ...

Lilly’s appeal of an earlier, negative recommendation from a key EMA committee has worked out in its favor, and puts the drug ...

European regulators said that Eli Lilly’s Alzheimer’s treatment Kisunla should be approved for select patients.

The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

The drug is administered subcutaneously twice a year, making it easier for high-risk patients to comply with prophylaxis.

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...

He has a track record of working with the European Union regulatory network. He previously led the Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority ...