BioMarin to Submit Temporary Gene Therapy to US and European Regulators in Fourth Quarter

BioMarin Pharmaceutical said that it plans to submit marketing applications to both the U.S. Food and Drug Administration and the European Medicines Agency in the fourth quarter of this year for its experimental Hemophilia A gene therapy.


The decision puts BioMarin on track to be the first company to seek regulatory approval for a hemophilia gene therapy of any kind.



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