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U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ...
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Fusion42 · 13 August 2026 · Fusion42 review
The U.S. FDA has granted accelerated approval to Bristol Myers Squibb's ZENBEXUS™, the first CELMoD therapy, for treating adult patients with multiple myeloma who have had at least one prior therapy. This approval is based on Phase 3 trial results showing significant improvement in minimal residual disease-negative complete response.
This Wire brief sits within Fusion42's coverage of Biotech, and 12 sources have reported it between 13 Aug 2026 and 17 Aug 2026.
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You must now integrate CELMoD therapy into treatment plans or clinical trials for multiple myeloma as this marks a new drug class gaining regulatory acceptance, shifting therapeutic approaches and research priorities.
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12 sources · first reported 13 Aug 2026 · latest 17 Aug 2026
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