FDA Action Update, June 2026: Acceptances, Clearances, and Alignments
β’ The FDA issued several decisions in June 2026 regarding new neurology therapeutic agents, including new drug application acceptances and regulatory alignments. β’ Key Duchenne Muscular Dystrophy (DMD) actions include the acceptance of Sareptaβs sNDAs to transition casimersen and golodirsen to traditional approvals. β’ A critical Advisory Committee (AdComm) meeting has been scheduled for July 29 to review the Biologics License Application (BLA) for deramiocel.
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