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’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Gilead ...

AGC Biologics’ Milan site achieved its 10th product approval from a major regulatory body after the EU granted marketing authorization for AUCATZYL®.

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 EU's medicines regulator said it would approve the treatment for a limited group of patients, citing concerns over side effects ...

Kisunla’s active substance is donanemab, a monoclonal antibody that targets and clears amyloid-beta plaques in the brain, a ...

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

European regulators said that Eli Lilly’s Alzheimer’s treatment Kisunla should be approved for select patients.