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CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission ...
The designation was based on the therapy’s novel mechanism and data showing its anti-tumour activity in B-cell malignancies.
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Medicines Agency (EMA) has ...
The European Medicines Agency has recommended authorizing a twice-yearly injectable drug to prevent HIV. Scientists say this ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Gilead ...
The European Medicines Agency (EMA) cleared the way for the use of another drug to treat Alzheimer's disease on Friday.
Certara, Inc., a global leader in biosimulation, today announced that the European Medicines Agency (EMA) has formally qualified the Simcyp® Simulator for use in regulatory submissions across the EU.
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.
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 ...