BMY
Iberdomide + daratumumab/dexamethasone
FDA PDUFA Target Action Date · Bristol-Myers Squibb Company
Monday, August 17, 2026
Approved
approved Note: Approved 2026-08-13 as ZENBEXUS (ORIG NDA221075). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-28; 4d from the PDUFA date.
Drug Information
- Application Type
- NDA
- FDA Designations
- BreakthroughPriority Review
- Indication
- Relapsed or refractory multiple myeloma
- Approved As
- Iberdomide + daratumumab/dexamethasone
Filing Details
- Company
- Bristol-Myers Squibb Company →
- Stock Ticker
- BMY
- SEC CIK
- 0000014272
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue