A recent decision by the Food and Drug Administration (FDA) has denied approval for MDMA therapy for post-traumatic stress disorder (PTSD). The decision comes after a Phase 3 clinical trial showed positive results for the therapy, known as MDMA-assisted psychotherapy. The FDA expressed concerns about the potential risks and long-term effects of MDMA, prompting the request for additional data and analysis from the therapy's manufacturer, MAPS. This denial of approval is a setback for advocates of MDMA therapy for PTSD, as the therapy aims to provide relief for individuals with treatment-resistant PTSD. The FDA's decision highlights the need for further research and evidence to support the safety and efficacy of MDMA therapy for PTSD [10633093].