Brief: FDA Accepts Biomarin's Palynziq Supplemental BLA For Priority Review To Expand Use To Adolescents Aged 12-17 With Phenylketonuria

BioMarin Pharmaceutical

29/10/2025 14:25

Oct 29 (Reuters) - Biomarin Pharmaceutical Inc BMRN.O:

FDA ACCEPTS BIOMARIN'S PALYNZIQ® (PEGVALIASE-PQPZ) SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR PRIORITY REVIEW TO EXPAND USE TO ADOLESCENTS AGED 12-17 WITH PHENYLKETONURIA

FDA ACCEPTS BIOMARIN'S PALYNZIQ® (PEGVALIASE-PQPZ) SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR PRIORITY REVIEW TO EXPAND USE TO ADOLESCENTS AGED 12-17 WITH PHENYLKETONURIA

BIOMARIN PHARMACEUTICAL INC - FDA PDUFA TARGET ACTION DATE SET FOR FEB. 28, 2026

Source text: ID:nPn9hy6GLa

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