tislelizumab PDUFA date: FDA decision expected May 27, 2027
The FDA is expected to decide on tislelizumab from Royalty Pharma plc in pediatric Tourette syndrome and granted the application Priority Review with a PDUFA date late in the first quarter of 2027 by the PDUFA target action date of May 27, 2027. For pediatric Tourette syndrome and granted the application Priority Review with a PDUFA date late in the first quarter of 2027. nda filing. Extracted from SEC filing: EX-99.1
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 November 6, 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 tislelizumab?
- The FDA's PDUFA target action date for tislelizumab is May 27, 2027. The FDA can act before that date, and the review can be extended.
- What is tislelizumab being reviewed for?
- The application under FDA review covers pediatric Tourette syndrome and granted the application Priority Review with a PDUFA date late in the first quarter of 2027.
- Which company is developing tislelizumab?
- Royalty Pharma plc (RPRX).
- 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).