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BioMarin Provides Update on FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) Gene Therapy for Adults with Severe Hemophilia A

/PRNewswire/ BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today.

Hank fuchsMarni kottleTraci mccartyDevelopment of biomarinEuropean commissionDrug administrationBiomarin pharmaceutical incExchange commissionWorldwide researchPrnewswire biomarin pharmaceutical incEuropean medicines agencyRobust clinical programTarget action dateMarin pharmaceuticalBiologics license applicationMajor amendment

FDA Extends Review Period for Valoctocogene Roxaparvovec for Hemophilia A

The FDA has extended the review period for the BLA for valoctocogene roxaparvovec for the treatment of hemophilia A in adults.

Hank fuchsWorldwide researchDevelopment of biomarinBiologics license applicationPrescription drug user fee actComplete response letter

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