FDA holds psychedelic forum as Definium reports third successful Phase 3 trial of oral LSD for anxiety
The FDA convened a public forum on Monday to discuss the near‑term outlook for psychedelic drug development, highlighting interest from companies such as Compass Pathways and Definium Therapeutics.
On Wednesday the agency will meet to consider recommendations for reauthorizing the Prescription Drug User Fee Act, a key funding mechanism for drug reviews.
Definium Therapeutics announced topline results from its third successful Phase 3 trial of an oral LSD formulation, the second trial showing benefit in generalized anxiety disorder, moving the candidate closer to potential approval.
The announcements come as Novartis continues to manage setbacks from a recent triple‑asset disappointment, though the article provides limited detail.
This writeup was produced by pharmadog from original reporting by BioSpace.
Original headline: “FDA hears input on psychedelics, PDUFA, lung cancer’s next-gen therapies boost survival”
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