FDA accepts BioMarin VOXZOGO full-approval application for children with achondroplasia - BMRN News | RalliesFDA accepts BioMarin VOXZOGO full-approval application for children with achondroplasia
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BMRN• FDA accepts BioMarin full-approval filing for VOXZOGO
- FDA accepted BioMarin’s sNDA seeking full approval of VOXZOGO for children with achondroplasia.
- PDUFA target action date set for Feb. 28, 2027.
- Filing aims to convert the drug’s 2021 accelerated approval into traditional approval, supported by long-term data from three ongoing studies.
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