The European Commission has approved AstraZeneca and Daiichi Sankyo’s Enhertu with pertuzumab for first-line HER2-positive metastatic breast cancer after DESTINY-Breast09 showed a 44% reduction in the risk of progression or death compared with long-standing THP therapy.
Europe has approved teclistamab plus daratumumab after MajesTEC-3 showed an 83.4% reduction in progression or death and a significant overall-survival advantage versus established regimens.
EU approval moves TECVAYLI plus daratumumab into earlier multiple myeloma treatment after Phase 3 data cut progression risk by 83.4%.
EU approval moves Datroway into first-line metastatic TNBC after TROPION-Breast02 showed survival gains, intensifying the TROP2 ADC race.
Roche’s Susvimo wins a positive European opinion for wet AMD. See how two yearly refills could reduce injections and reshape retinal care.
CHMP backs Ubeslo and Evlarco, moving obicetrapib closer to European authorization while PREVAIL tests cardiovascular outcomes.
EU regulators back Enhertu plus pertuzumab for first-line HER2-positive metastatic breast cancer, shifting focus to approval, safety and access.
Leriglitazone wins a positive European opinion for boys with early cerebral adrenoleukodystrophy after a narrower pediatric application.
CHMP backs Trodelvy plus Keytruda for first-line PD-L1-positive metastatic TNBC, moving Gilead closer to an expanded EU label.
Crysvita wins European Union approval for infants from one month, widening early XLH treatment and strengthening Kyowa Kirin’s rare disease franchise.