CMA for BMRN - BMRN will receive a “Conditional marketing authorisation“ -for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A- “The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.”
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