MDMA-Assisted Therapy NDA Resubmitted to FDA for PTSD

Resilient Pharmaceuticals resubmitted its NDA for MDMA-assisted therapy for PTSD to the FDA without a new phase 3 trial, addressing the agency's previous concerns on durability, safety, and bias mitigation. The FDA finalized new guidance on psychedelic drug clinical trials in July 2026, setting standards for trial design, safety, therapist involvement, and follow-up.

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