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- FDA holds psychedelic forum as Definium reports third successful Phase 3 trial of oral LSD for anxietyThe 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.…
- Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meetingThe FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal…