Podcast: Usona Files Psilocybin Application, FDA Comments Are Reviewed, and NRx’s Generic Ketamine Is Approved

The episode reviews major developments in the psychedelics field over a two-week period. It covers Usona Institute’s filing of a psilocybin new drug application for major depressive disorder, FDA approval of NRx Pharmaceuticals’ preservative-free generic ketamine, and an analysis of 610 public comments submitted to the FDA’s psychedelics docket. The discussion also previews ICER’s planned review of Compass Pathways’ psilocybin treatment for treatment-resistant depression and shares additional takeaways from the Psychedelic Healthcare Forum, alongside other industry stories. The episode places these developments in the context of advancing psychedelic therapies, regulatory review, pharmaceutical competition, and the need for evidence generation, pharmacovigilance, and comprehensive risk management focused on patient safety.