The FDA (the US drug regulator) will not give MDMA or psilocybin full legal drug status by mid-August 2026. Neither substance even has a review deadline scheduled in that window. This means doctors still cannot officially prescribe either drug as an approved medicine.
No MDMA or psilocybin NDA/BLA has an FDA action date within the next 30 days, and any pending resubmission would require a public review timeline. A near-term approval is effectively ruled out.
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