U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD ...

The U.S. FDA has granted accelerated approval to Bristol Myers Squibb's ZENBEXUS (iberdomide), the first CELMoD therapy, in combination with daratumumab, hyaluronidase-fihj, and dexamethasone (ZDd) for adults with multiple myeloma after at least one prior treatment line. This approval is based on Phase 3 trial results showing significant improvement in minimal residual disease-negative complete response, marking a new treatment class for relapsed or refractory multiple myeloma.

This Wire brief sits within Fusion42's coverage of Biotech, and 12 sources have reported it between 13 Aug 2026 and 17 Aug 2026.