Podcast: Usona Files Psilocybin Application, We Review 610 Comments Submitted to FDA, and FDA Approves NRx’s Generic Ketamine
In this episode of The Psychedelic News Feed podcast, Psychedelic Alpha’s editor Josh Hardman runs through the last two weeks in the psychedelics field, including these stories:
- Usona Institute files its psilocybin for major depressive disorder new drug application with FDA
- FDA approves NRx Pharmaceuticals’ preservative-free generic ketamine
- We share our analysis of 610 public comments on FDA’s psychedelics docket
- ICER is set to review Compass Pathways’ psilocybin for treatment-resistant depression
- More takeaways from The Psychedelic Healthcare Forum
- Other stories
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- Usona Files Psilocybin for Depression NDA as Race With Compass Tightens
- Mostly Supportive, Somewhat Divided: Stakeholders Respond to FDA’s Psychedelics Docket
- FDA Approves NRx’s Preservative-Free Generic Ketamine, but Its Bid to Ban Rivals’ Products Remains Pending
- Pharma Moves In: Investors, Developers and Lilly’s Carole Ho at the Psychedelic Healthcare Forum
- Take part in Johns Hopkins’ psychedelic research survey
This episode of The Psychedelic News Feed is supported by
As psychedelic therapies move toward potential approvals, UBC helps sponsors navigate the evidence generation, pharmacovigilance, and comprehensive risk management strategies that support a path forward grounded in patient safety.
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