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BioMarin Resubmits Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Severe Hemophilia A to the FDA

/PRNewswire/ BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the Company resubmitted a Biologics License Application (BLA) to the U.S. Food.

United statesHank fuchsDebra charlesworthTraci mccartyEuropean commissionDrug administrationBiomarin pharmaceutical incExchange commissionWorldwide researchPrnewswire biomarin pharmaceutical incEuropean unionEuropean medicines agencyRobust clinical programSubstantial bodyPivotal phaseOngoing phase

BioMarin Resubmits Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Severe Hemophilia A to the FDA

/PRNewswire/ BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the Company resubmitted a Biologics License Application (BLA) to the U.S. Food.

United statesHank fuchsDebra charlesworthTraci mccartyEuropean commissionDrug administrationBiomarin pharmaceutical incExchange commissionWorldwide researchPrnewswire biomarin pharmaceutical incEuropean unionEuropean medicines agencyRobust clinical programSubstantial bodyPivotal phaseOngoing phase

BioMarin s Gene Therapy for Adults with Severe Hemophilia A, ROCTAVIAN™ (valoctocogene roxaparvovec), Assessed to Provide Substantial Cost Savings Per Patient in a Preliminary Independent Report

/PRNewswire/ BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the Institute for Clinical and Economic Review (ICER) released a Draft.

United statesJeff ajerDebra charlesworthTraci mccartyExchange commissionInstitute for clinicalEuropean unionBiomarin pharmaceutical incEconomic reviewBase case model report resultsLicense applicationBiomarin pharmaceuticalDraft evidence reportExecutive vice presidentChief commercial officerBiologics license application

First Gene Therapy for Adults with Severe Hemophilia A, BioMarin s ROCTAVIAN™ (valoctocogene roxaparvovec), Approved by European Commission (EC)

First Gene Therapy for Adults with Severe Hemophilia A, BioMarin s ROCTAVIAN™ (valoctocogene roxaparvovec), Approved by European Commission (EC)
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

Nordrhein westfalenUnited statesJohannes oldenburgDebra charlesworthJean jacques bienaimTraci mccartyUniversity clinic in bonnEuropean commissionBiomarin pharmaceutical incHaemophilia centreReplay international numberExchange commissionInternational numberPrnewswire biomarin pharmaceutical incEuropean medicines agencyRobust clinical program

First Gene Therapy for Adults with Severe Hemophilia A, BioMarin s ROCTAVIAN™ (valoctocogene roxaparvovec), Approved by European Commission (EC)

First Gene Therapy for Adults with Severe Hemophilia A, BioMarin s ROCTAVIAN™ (valoctocogene roxaparvovec), Approved by European Commission (EC)
apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.

Nordrhein westfalenUnited statesJohannes oldenburgDebra charlesworthJean jacques bienaimTraci mccartyUniversity clinic in bonnEuropean commissionBiomarin pharmaceutical incHaemophilia centreReplay international numberExchange commissionInternational numberPrnewswire biomarin pharmaceutical incEuropean medicines agencyRobust clinical program

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