Obinutuzumab/Intravenous PDUFA date: FDA decision expected November 30, 2026
The FDA is expected to decide on Obinutuzumab/Intravenous from Roche Holding AG in Primary membranous nephropathy by the PDUFA target action date of November 30, 2026. For Primary membranous nephropathy. sBLA, Priority Review; company says by November 2026, no exact day. Verified against the company announcement on 2026-10-16.
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: roche.com · Data checked November 11, 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 Obinutuzumab/Intravenous?
- The FDA's PDUFA target action date for Obinutuzumab/Intravenous is November 30, 2026. The FDA can act before that date, and the review can be extended.
- What is Obinutuzumab/Intravenous being reviewed for?
- The application under FDA review covers Primary membranous nephropathy.
- Which company is developing Obinutuzumab/Intravenous?
- 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).