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BioMarin sNDA seeking full Voxzogo approval accepted by FDA

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  • An sNDA filed by BioMarin Pharmaceutical (BMRN) seeking full approval of its achondroplasia treatment Voxzogo (vosoritide) has been accepted by the US FDA.
  • The action date is Feb. 28, 2027.
  • The application is supported by three long-term trials. 
  • The therapy was granted accelerated approval in 2021.
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