No FDA approval of psilocybin or MDMA-based therapy issued in 2026

The US drug regulator (FDA) won't officially approve psilocybin (the active compound in magic mushrooms) or MDMA-assisted therapy this year. Getting approval requires completing a massive paperwork package, a months-long government review, and a public expert panel — there simply isn't enough time in 2026 for all of that to happen. So people hoping to access these treatments through traditional clinics or insurance will keep waiting.

Even a positive Phase 3 readout this year requires NDA assembly, a multi-month review cycle, and likely an advisory committee. The timeline is mechanically impossible within calendar 2026 regardless of political pressure.