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March 2, 2026

BioMarin receives FDA approval for Palynziq use in adolescents

BioMarin Pharmaceutical has received the US Food and Drug Administration (FDA) approval for its supplemental biologics licence application (sBLA) for Palynziq’s (pegvaliase-pqpz) use in adolescents aged 12 and above with phenylketonuria (PKU).

Palynziq is the only enzyme substitution therapy approved to reduce blood phenylalanine concentrations in individuals with phenylketonuria. Credit: Jack_the_sparrow / Shutterstock.com.