Story perspectives

FDA Accelerates Psychedelic Drug Reviews, Grants Priority Vouchers

4/25/2026

Summary

Story summary

FDA announced it will compress psychedelic drug reviews to weeks, the fastest timeline for therapy.
After President Donald Trump’s April 18 executive order, the FDA gave priority review vouchers to Compass Pathways, Usona Institute and Transcend Therapeutics for psilocybin-methylone treatments targeting depression and PTSD.
FDA Commissioner Marty Makary said the agency owes it to veterans and Americans to evaluate these therapies, noting that Compass Pathways targets launch by year-end.

History

Historical Context

In 1992 the FDA launched its accelerated approval and Fast Track pathways, cutting typical drug review from about 30 months to 15 months and speeding AIDS therapies such as zidovudine. Building on that framework, the agency now grants priority review vouchers to firms like Compass Pathways and Usona Institute for psilocybin-based treatments, aiming to deliver depression and PTSD drugs within a year.

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Story summary

FDA announced it will compress psychedelic drug reviews to weeks, the fastest timeline for therapy.
After President Donald Trump’s April 18 executive order, the FDA gave priority review vouchers to Compass Pathways, Usona Institute and Transcend Therapeutics for psilocybin-methylone treatments targeting depression and PTSD.
FDA Commissioner Marty Makary said the agency owes it to veterans and Americans to evaluate these therapies, noting that Compass Pathways targets launch by year-end.

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