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Medical Daily
Medical Daily
Health
Cole Mercer

Psilocybin Could Become the First FDA-Approved Psychedelic Therapy Within Months — Here Is What Patients Need to Know

For the first time in U.S. history, a psychedelic drug may be on the verge of FDA approval as a prescription treatment for a psychiatric condition. And the regulatory timeline has compressed significantly in the past two months.

On April 18, 2026, President Trump signed an executive order directing federal agencies to accelerate the research, review, and approval of psychedelic drugs as treatments for serious mental health conditions. Just six days later, FDA Commissioner Marty Makary issued National Priority Vouchers to three psychedelic therapy programs — vouchers that can compress the FDA's standard 10-to-12-month drug application review to one to two months.

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