PALYNZIQ (pegvaliase) PDUFA Date (BioMarin Pharmaceutical)

Name: FDA PDUFA Decision: PALYNZIQ (pegvaliase)
Start: 2026-02-28

FDA PDUFA decision date for PALYNZIQ (pegvaliase) is February 28, 2026. Developed by BioMarin Pharmaceutical. Indication: Phenylketonuria (adolescents 12-17). Current status: Approved.

Indication

Phenylketonuria (adolescents 12-17)

Regulatory details

Company: BioMarin Pharmaceutical
Therapeutic area: Rare Disease / Metabolic
Application type: sBLA
Review type: Standard
PDUFA date: 2026-02-28
Outcome: Approved

PALYNZIQ (pegvaliase) PDUFA Date — BioMarin Pharmaceutical