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BioMarin: FDA accepts for Priority Review sBLA for Palynziq

BioMarin (BMRN) Pharmaceutical announced that the U.S. FDA has accepted for Priority Review the company’s Palynziq supplemental Biologics License Application to expand treatment to include adolescents aged 12-17 with phenylketonuria. The FDA has set a Prescription Drug User Fee Act target action date of Feb. 28, 2026

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