mezigdomide PDUFA date: FDA decision expected May 13, 2027
The FDA is expected to decide on mezigdomide from Bristol-Myers Squibb Company in relapsed or refractory multiple myeloma (RRMM), in combination with carfilzomib and dexamethasone (MeziKd) by the PDUFA target action date of May 13, 2027. For relapsed or refractory multiple myeloma (RRMM), in combination with carfilzomib and dexamethasone (MeziKd). NDA filing. Extracted from SEC filing: PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED JULY 30, 2026
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 25, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for mezigdomide?
- The FDA's PDUFA target action date for mezigdomide is May 13, 2027. The FDA can act before that date, and the review can be extended.
- What is mezigdomide being reviewed for?
- The application under FDA review covers relapsed or refractory multiple myeloma (RRMM), in combination with carfilzomib and dexamethasone (MeziKd).
- Which company is developing mezigdomide?
- Bristol-Myers Squibb Company (BMY).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).