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

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

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

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

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

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.