FDA to speed up review of 3 psychedelics as mental health treatments


Damian Garde is a reporter at large, live and feature journalism, covering the global drug industry and contributing to STAT’s industry-leading events.

The Food and Drug Administration will accelerate its review of psychedelic drugs developed by Compass Pathways, the Usona Institute, and Transcend Therapeutics for mental health disorders, as part of the Trump administration’s plan to boost access to the controversial, yet promising medications.

The agency will grant priority review vouchers specifically to Compass’ psilocybin product for treatment-resistant depression, Usona’s similar medicine for major depressive disorder, and an MDMA-like treatment for post-traumatic stress disorder from Transcend. 

The FDA identified the medications receiving the vouchers, but not the companies developing them. Compass confirmed it received a voucher, while the other firms were identified by a person familiar with the matter.

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