BioMarin (BMRN) said the U.S. FDA accepted its supplemental NDA (sNDA) for VOXZOGO (vosoritide) to secure full approval for use in children with achondroplasia. The FDA has set a Prescription Drug User Fee Act (PDUFA) decision milestone (details not provided in the excerpt). Overall, this is a positive regulatory step that can support broader commercialization prospects, but likely limited near-term market impact without approval timing or additional data.
BioMarin (BMRN) said the U.S. FDA accepted its supplemental NDA (sNDA) for VOXZOGO (vosoritide) to secure full approval for use in children with achondroplasia. The FDA has set a Prescription Drug User Fee Act (PDUFA) decision milestone (details not provided in the excerpt). Overall, this is a positive regulatory step that can support broader commercialization prospects, but likely limited near-term market impact without approval timing or additional data.
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