Upcoming FDA decision · November 22, 2026
Molgramostim PDUFA date: FDA decision expected November 22, 2026
37 days to goSavara Inc (SVRA) →
The FDA is expected to decide on Molgramostim from Savara Inc in Autoimmune pulmonary alveolar proteinosis by the PDUFA target action date of November 22, 2026. For Autoimmune pulmonary alveolar proteinosis. BLA, Priority Review; extended from Aug 22 after a major amendment. 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: businesswire.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
November 22
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Molgramostim?
- The FDA's PDUFA target action date for Molgramostim is November 22, 2026. The FDA can act before that date, and the review can be extended.
- What is Molgramostim being reviewed for?
- The application under FDA review covers Autoimmune pulmonary alveolar proteinosis.
- Which company is developing Molgramostim?
- Savara Inc (SVRA).
- 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).