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FDA Denies Approval of New Drug Application for MDMA and Requests Additional Study
16 September 2024
Phillips Lytle LLP
As the therapeutic potential of psychedelics continues to gain traction in the medical community, recent developments surrounding the U.S. Food and Drug Administration’s (FDA) decision on Lykos Therapeutics’ MDMA new drug application (NDA) have sparked considerable debate. This article explores the implications of the FDA’s decision, lessons for developers, and the future trajectory of psychedelic therapies
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