PDUFA Date
BMY: FDA Decision: zenbexus
August 13, 2026 · zenbexus · approval. BioSniper AI can trace the company-impact path without requiring you to write the research question.
- Event date
- August 13, 2026
- Company
- BRISTOL MYERS SQUIBB CO (BMY)
- Drug
- zenbexus
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PDUFA Dateapproval
FDA Decision: zenbexus
- Drug
- zenbexus
- Indication
- 1 INDICATIONS AND USAGE ZENBEXUS is indicated, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time [see Clinical Studies (14) ] . Continued approval for this indicati
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