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 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 ...

REYKJAVIK, Iceland and LONDON, June 23, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...

About the author Chris Spivey is the editorial director of Pharmaceutical Technology Europe. Article details Pharmaceutical Technology Europe Volume 36, No. 2 February 2024 Pages 11–14 Citation When ...

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