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 ...

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 ...

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 has recommended authorizing a twice-yearly injectable drug to prevent HIV. Scientists say this ...

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

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.

On July 2, linvoseltamab-gcpt (Lynozyfic; Regeneron) received an accelerated approval from the FDA in relapsed/refractory ...

Reports second quarter revenues of $0.1 billion, GAAP net loss of $(0.8) billion and GAAP EPS of $(2.13) Updates 2025 ...