Phase III FENtrepid trial results show investigational BTK inhibitor fenebrutinib met its primary endpoint of non-inferiority to ocrelizumab in primary progressive MS, with a 12% reduction in disability progression risk and strongest effect on upper limb function.
Retrospective analysis of the ZUMA-2 trial found that previous ibrutinib exposure was associated with improved progression-free survival after brexucabtagene autoleucel treatment in mantle cell lymphoma patients, though with increased toxicity.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.