Tags : Valoctocogene Roxaparvovec

Regulatory

BioMarin Reports Submission of MAA to EMA for Valoctocogene Roxaparvovec

Shots: The MAA submission is based on ongoing P-III study with material from the to-be-commercialized process and updated 3yrs. P-I/II data. The submission marks the first MAA submission for a gene therapy product targeting any type of hemophilia BioMarin is expected its MAA for Valoctocogene Roxaparvovec to be reviewed under expedited accelerated assessment designation in […]Read More