FDA Action Update, June 2026: Acceptances, Clearances, and Alignments
• The FDA issued several decisions in June 2026 regarding new neurology therapeutic agents, including new drug application acceptances and regulatory alignments. • Key Duchenne Muscular Dystrophy (DMD) actions include the acceptance of Sarepta’s sNDAs to transition casimersen and golodirsen to traditional approvals. • 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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