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Home › PDUFA Calendar › BMRN

BMRN PDUFA Date: VOXZOGO

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET
FDA decision (PDUFA) target Feb 28, 2027 · Biomarin Pharmaceutical Inc · Children with achondroplasia (application for full approval)
Source: BioMarin 8-K 2026-11-02 (EX-99.1, Q3 2026 results). “BioMarin's application for full approval of VOXZOGO in children with achondroplasia is under review by the FDA, with a PDUFA target action date of February 28, 2027.”

Also under FDA review from Biomarin Pharmaceutical Inc, as a separate application: VOXZOGO, May 30, 2027. One application, one page; this page is the application with the Feb 28, 2027 goal date.

Key facts

FDA PDUFA target date2027-02-28
Drug / candidateVOXZOGO (vosoritide)
IndicationChildren with achondroplasia (application for full approval)
CompanyBiomarin Pharmaceutical Inc
Market-cap tierLarge

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FAQ

When is the BMRN PDUFA date?
The FDA PDUFA target date for BMRN (Biomarin Pharmaceutical Inc) is 2027-02-28 for VOXZOGO (vosoritide). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BMRN's drug VOXZOGO?
VOXZOGO (vosoritide) is Biomarin Pharmaceutical Inc's candidate under FDA review for Children with achondroplasia (application for full approval).