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

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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 (EMA) cleared the way for the use of another drug to treat Alzheimer's disease on Friday.

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 ...

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 ...

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 ...