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 ...

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

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

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 ...

(NASDAQ:MRNA) today reported financial results and provided business updates for the second quarter of 2025. "In the last three months, we advanced our pipeline with positive Phase 3 flu vaccine ...