BMRN PDUFA Date: VOXZOGO

Name: VOXZOGO FDA decision
Start: 2027-05-30
End: 2027-05-30

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

FDA decision (PDUFA) target May 30, 2027 · Biomarin Pharmaceutical Inc · Hypochondroplasia

Source: BioMarin 8-K 2026-11-02 (EX-99.1, Q3 2026 results). “Food and Drug Administration (FDA) has set a PDUFA target action date of May 30, 2027…”

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

Key facts

FDA PDUFA target date2027-05-30

Drug / candidateVOXZOGO (vosoritide)

IndicationHypochondroplasia

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 2027-05-30 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 Hypochondroplasia.