Upcoming FDA decision · February 28, 2027
Vosoritide Injection PDUFA date: FDA decision expected February 28, 2027
135 days to goBioMarin Pharmaceutical Inc. (BMRN) →
The FDA is expected to decide on Vosoritide Injection from BioMarin Pharmaceutical Inc. in Achondroplasia in children (full approval) by the PDUFA target action date of February 28, 2027. For Achondroplasia in children (full approval). sNDA for full approval. Verified against the company SEC filing 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: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
February 28
Target action date
Phase 2
Stage
Verified
Date confidence
—
FDA designations
Questions about this FDA decision
- When is the PDUFA date for Vosoritide Injection?
- The FDA's PDUFA target action date for Vosoritide Injection is February 28, 2027. The FDA can act before that date, and the review can be extended.
- What is Vosoritide Injection being reviewed for?
- The application under FDA review covers Achondroplasia in children (full approval).
- Which company is developing Vosoritide Injection?
- BioMarin Pharmaceutical Inc. (BMRN).
- 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).