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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 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 ...
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 ...
Lilly’s appeal of an earlier, negative recommendation from a key EMA committee has worked out in its favor, and puts the drug ...
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 ...