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BioMarin resubmits haemophilia A gene therapy to the EMA pharmatimes
June 30, 2021
BioMarin has resubmitted a marketing authorisation application (MAA) for its haemophilia A gene therapy valoctocogene roxaparvovec to the European Medicines Agency (EMA), the company announced 28th.
BioMarin Announces RMAT Designation Granted to Valoctocogene Roxaparvovec for Hemophilia A americanpharmaceuticalreview
March 11, 2021
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe ...
BioMarin Expands Vosoritide Clinical Program americanpharmaceuticalreview
November 18, 2020
BioMarin Pharmaceutical announced the Company is expanding its clinical program for vosoritide, an investigational analog of C-type Natriuretic Peptide (CNP), with two new Phase 2 studies.
BioMarin Receives FDA Fast Track Designation for PKU Investigational Gene Therapy americanpharmaceuticalreview
October 12, 2020
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BMN 307, an investigational gene therapy for the treatment of individuals with PKU.
EU review extended for BioMarin's gene therapy Valrox pharmatimes
September 24, 2020
European regulators have requested more data to review the marketing application for BioMarin's haemophilia A gene therapy Valrox (valoctocogene roxaparvove).
BioMarin Receives CRL for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A americanpharmaceuticalreview
August 21, 2020
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the Company's Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy for severe hemophilia A.
BioMarin to Begin Clinical Trial with BMN 307 Gene Therapy americanpharmaceuticalreview
January 17, 2020
BioMarin announced both the U.S. Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. have granted the Company Investigational New Drug (IND) status and approved its Clinical Trial Application (
BioMarin Submits CTA in UK for Investigational Gene Therapy for PKU americanpharmaceuticalreview
September 27, 2019
BioMarin Pharmaceutical has submitted a Clinical Trial Application (CTA) with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. for BMN 307 ...
BioMarin Announces New England Journal of Medicine Publishes Vosoritide Phase 2 Study Showing Sustained Annualized Growth Up to 42 Months in Children with Achondroplasia drugs
June 24, 2019
BioMarin Announces New England Journal of Medicine Publishes Vosoritide Phase 2 Study Showing Sustained Annualized Growth Up to 42 Months in Children with Achondroplasia.
BioMarin Announces Valoctocogene Roxaparvovec Gene Therapy Study in Severe Hemophilia A Met Pre-Specified Criteria americanpharmaceuticalreview
May 29, 2019
BioMarin Pharmaceutical announced its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A achieved pre-specified clinical criteria for regulatory review in the U.S. and Europe.

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