FDA Rejects Application for Psychedelic Drug

The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos submitted the application to secure FDA approval for use of the drug to treat post-traumatic stress disorder (PTSD). No……
By: Holland & Knight LLP