The designation was based on the therapy’s novel mechanism and data showing its anti-tumour activity in B-cell malignancies.

Kisunla’s active substance is donanemab, a monoclonal antibody that targets and clears amyloid-beta plaques in the brain, a ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Gilead ...

CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission ...

The EU's medicines regulator said it would approve the treatment for a limited group of patients, citing concerns over side effects ...

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

The European drug authority recommends refusal of marketing authorization due to evidence gaps in quality and efficacy.

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

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

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of Vyjuvek for the treatment of wounds in patients with dystrophic epidermolysis bullosa ...

On July 2, linvoseltamab-gcpt (Lynozyfic; Regeneron) received an accelerated approval from the FDA in relapsed/refractory ...