Mosunetuzumab PDUFA date: FDA decision expected February 9, 2027
The FDA is expected to decide on Mosunetuzumab from Roche Holding AG in Relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) by the PDUFA target action date of February 9, 2027. For Relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL). sBLA filing. AI-extracted from news: FDA accepts supplemental Biologics License Application for Roche’s Lunsumio and Polivy combination f
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: globenewswire.com · Data checked November 12, 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 Mosunetuzumab?
- The FDA's PDUFA target action date for Mosunetuzumab is February 9, 2027. The FDA can act before that date, and the review can be extended.
- What is Mosunetuzumab being reviewed for?
- The application under FDA review covers Relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL).
- Which company is developing Mosunetuzumab?
- Roche Holding AG (RHHBY).
- 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).