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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

BioMarin Pharma (BMRN) Reports Stable and Durable Annualized Bleed Control for ROCTAVIAN in Phase 3 Study

BioMarin Pharma (BMRN) Reports Stable and Durable Annualized Bleed Control for ROCTAVIAN in Phase 3 Study
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Jeff ajerMarni kottleTraci mccartyExchange commissionEuropean medicines agencyEuropean commissionBiomarin pharmaceutical incRobust clinical programMarin pharmaceuticalCommercial progressExecutive vice presidentChief commercial officerBiologics license applicationPre license inspectionRegenerative medicine advanced therapyBreakthrough therapy designation

BioMarin Announces Advancements in FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) for Adults with Severe Hemophilia A

/PRNewswire/ BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced advancements in the U.S. Food and Drug Administration (FDA) review of the Biologics.

Hank fuchsDebra charlesworthTraci mccartyWorldwide researchExchange commissionEuropean commissionDrug administrationBiomarin pharmaceutical incRobust clinical programLonger plansAdvisory committee meetingPreviously plannedBiologics license applicationMarin remainsHost scheduled manufacturing inspectionsBiomarin pharmaceutical

BioMarin Announces Incremental Progress on Biologics License Application (BLA) Review for Valoctocogene Roxaparvovec AAV Gene Therapy for Adults with Severe Hemophilia A Program

/PRNewswire/ BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today a progress update on its Biologics License Application (BLA) for valoctocogene.

Hank fuchsDebra charlesworthTraci mccartyEuropean commissionDrug administrationBiomarin pharmaceutical incAdvisory committeeExchange commissionWorldwide researchPrnewswire biomarin pharmaceutical incRobust clinical programLicensure inspectionGene therapy manufacturing facilityYear data analysisAction dateCould be extended

FDA Accepts BioMarin s Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Adults with Severe Hemophilia A

If Approved, Would Be 1st Gene Therapy in U.S. for Treatment of Severe Hemophilia APDUFA Target Action Date is March 31, 2023SAN RAFAEL, Calif., O.

United statesHank fuchsDebra charlesworthTraci mccartyEuropean commissionDrug administrationBiomarin pharmaceutical incExchange commissionWorldwide researchPrnewswire biomarin pharmaceutical incRobust clinical programGene therapySevere hemophiliaAction dateMarin pharmaceuticalBiologics license application