FDA grants priority review for BridgeBio's achondroplasia drug

The FDA has accepted BridgeBio Pharma's New Drug Application for oral infigratinib, granting it Priority Review for children with achondroplasia. This decision addresses a significant unmet need for an oral targeted therapy for the genetic condition. A PDUFA target action date is set for February 4, 2027, with potential for infigratinib to become the first and only approved oral therapy for achondroplasia.