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

Published

13 August 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at lasvegassun.com →

◆ Verified

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.

◆ ◆ The Wire takeaway

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.

◆ Coverage

12 sources · first reported 13 Aug 2026 · latest 17 Aug 2026

◆ Topics

Biotechfda-approvalmultiple-myelomacelmodbiotechdrug-approval