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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: FDA No Longer Plans To Hold Advisory Committee Meeting To Discuss BLA

WASHINGTON (dpa-AFX) - BioMarin Pharmaceutical Inc. (BMRN) said the company was recently notified by the FDA that, at this time, the Agency no longer plans to hold an advisory committee meeting

United statesBiomarin pharmaceutical incMore such health newsMarin pharmaceuticalRegenerative medicine advanced therapyLicensure inspection

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

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