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CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission ...
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Medicines Agency (EMA) has ...
The designation was based on the therapy’s novel mechanism and data showing its anti-tumour activity in B-cell malignancies.
"Gilead wins positive European approval opinion for twice-yearly HIV injection" was originally created and published by ...
Certara Simcyp Simulator becomes first software platform to receive EMA qualification opinion for PBPK modelling: Radnor, Pennsylvania Tuesday, August 5, 2025, 12:00 Hrs [IST] Cer ...
The European Medicines Agency has recommended authorizing a twice-yearly injectable drug to prevent HIV. LONDON (AP) — The ...
Kisunla’s active substance is donanemab, a monoclonal antibody that targets and clears amyloid-beta plaques in the brain, a ...
European regulators said that Eli Lilly’s Alzheimer’s treatment Kisunla should be approved for select patients.
The European drug authority recommends refusal of marketing authorization due to evidence gaps in quality and efficacy.