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

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 ...

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Medicines Agency (EMA) has ...

FOSTER CITY, Calif., February 24, 2025--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s ...

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 ...

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

The European Medicines Agency (EMA) has finally joined the discussion on artificial intelligence (AI) and machine learning (ML), releasing a draft reflection paper on the use of these technologies ...

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 ...

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

The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in hematopoietic stem-cell transplant. About Hematopoietic stem cell transplant-associated thrombotic ...