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Medical Daily
Medical Daily
Health
Dorothy Brooks

The FDA Just Put Psilocybin and an MDMA-Like Drug on a 1-to-2 Month Approval Track. A Historic Mental Health Decision Is Coming.

For the millions of Americans with treatment-resistant depression or PTSD who have tried multiple medications and therapies without lasting relief, the prospect of a federally approved psychedelic treatment — once unthinkable in mainstream medicine — is now closer than at any point in modern regulatory history.

On April 24, 2026, the U.S. Food and Drug Administration issued National Priority Vouchers to three companies developing psychedelic-based therapies: Compass Pathways for its synthetic psilocybin (COMP360) for treatment-resistant depression; the Usona Institute for psilocybin for major depressive disorder; and Transcend Therapeutics for methylone (TSND-201, an MDMA-like compound) for PTSD. These vouchers were issued under the FDA Commissioner's National Priority Voucher pilot program — a mechanism that compresses the standard 10-to-12-month drug application review down to one to two months.

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