FDA Grants Priority Review for Oral Achondroplasia Treatment

The FDA has accepted BridgeBio Pharma's New Drug Application for oral infigratinib, granting it Priority Review for treating children with achondroplasia. This action addresses a significant unmet need for an oral therapeutic option for this rare genetic condition, with a PDUFA target date of February 4, 2027, following positive Phase 3 trial results.