NasdaqGS:BMRNBiotechs
BioMarin (BMRN) Wins FDA Review For VOXZOGO Full Approval In Achondroplasia
FDA accepts BioMarin Pharmaceutical's supplemental New Drug Application for VOXZOGO for children with achondroplasia.
Submission is based on extensive long-term safety and efficacy data from VOXZOGO treatment.
The filing aims to convert VOXZOGO's existing authorization into full approval and address a major post marketing requirement.
For BioMarin Pharmaceutical (NasdaqGS:BMRN), the FDA's acceptance of the VOXZOGO sNDA centers attention on its rare disease focus and its role in...