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 ...

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.

"Tevimbra is already approved in the EU across multiple settings in [non-small cell lung cancer], the most common form of lung cancer, and this positive CHMP opinion expands its potential to help ...

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

Eli Lilly said on Friday that the European Medicines Agency (EMA) has recommended approval of its drug Kisunla for certain ...

Eli Lilly and Co. won the backing of European Union regulators for its Alzheimer’s disease drug Kisunla in a specific group ...