Following the multi-decade regulatory pursuit, legal MDMA-assisted therapy (MDMA-AT) seemed imminent to many people. In February 2024, the FDA accepted Lykos Therapeutics’ New Drug Application (NDA), and all markers indicated a likely approval. However, on June 4, the Psychopharmacologic Drugs Advisory Committee (PDAC) shattered optimism when nearly all members advised the FDA to reject Lykos’ […]

The post What is MDMA’s FDA Approval Status? A Look Ahead appeared first on Psychedelics Today.

Previous articleNatural Medicine Advisory Bulletin 11.6: June 14th Subcommittee: Problems with Products
Next articleBuilding a Unified Psychedelic Future: Ethics, Standards, and a Path to Affordable Access