Tabelecleucel (Tab-cel®) PDUFA date: FDA decision expected March 31, 2027
The FDA is expected to decide on Tabelecleucel (Tab-cel®) from Atara Biotherapeutics, Inc. in EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD) by the PDUFA target action date of March 31, 2027. For EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD). BLA resubmission (Class 2) accepted.
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: drugs.com · Data checked October 20, 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 Tabelecleucel (Tab-cel®)?
- The FDA's PDUFA target action date for Tabelecleucel (Tab-cel®) is March 31, 2027. The FDA can act before that date, and the review can be extended.
- What is Tabelecleucel (Tab-cel®) being reviewed for?
- The application under FDA review covers EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
- Which company is developing Tabelecleucel (Tab-cel®)?
- Atara Biotherapeutics, Inc. (ATRA).
- 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).