San Jose, CA; September 4, 2025 — In August 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Lykos Therapeutics, declining to approve MDMA-assisted therapy for Posttraumatic Stress Disorder (PTSD). Today, the FDA made this CRL publicly available for the first time, providing transparency into the agency’s decision-making process. … Continue reading MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy| Multidisciplinary Association for Psychedelic Studies – MAPS
WASHINGTON, DC (August 14, 2025) — One year after the FDA’s denial of the New Drug Application for MDMA-assisted therapy for PTSD, the Multidisciplinary Association for Psychedelic Studies (MAPS) has issued an open letter to the U.S. Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr., and Dr. Martin A. Makary, the Commissioner… Continue reading MAPS Urges Action: Open Letter to HHS Secretary and FDA Commissioner One Year After FDA Denial of MDMA-Assisted Therapy for PTSD| Multidisciplinary Association for Psychedelic Studies – MAPS
FOR IMMEDIATE RELEASE: August 9, 2024| Multidisciplinary Association for Psychedelic Studies - MAPS