tabelecleucel PDUFA date: FDA decision expected March 31, 2027
The FDA is expected to decide on tabelecleucel from Bristol-Myers Squibb Company in EBV-positive post-transplant lymphoproliferative disease (PTLD) by the PDUFA target action date of March 31, 2027. For EBV-positive post-transplant lymphoproliferative disease (PTLD). BLA accepted. AI-extracted from: <![CDATA[FDA Accepts Resubmitted Tabelecleucel BLA for EBV-Positive PTLD]]>
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: cancernetwork.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
Questions about this FDA decision
- When is the PDUFA date for tabelecleucel?
- The FDA's PDUFA target action date for tabelecleucel is March 31, 2027. The FDA can act before that date, and the review can be extended.
- What is tabelecleucel being reviewed for?
- The application under FDA review covers EBV-positive post-transplant lymphoproliferative disease (PTLD).
- Which company is developing tabelecleucel?
- 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).