Keeping Track Of AdComms: US FDA Puts Donanemab On Schedule, Delays COVID-19 Meeting

 
• By Bridget Silverman
  
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Newly announced US FDA advisory committee meetings on Lilly’s Alzheimer’s antibody, Lykos’ pioneering psychedelic therapy for PTSD relieve drought in non-oncology AdComms as the 2024-‘25 COVID vaccine strain selection meeting is postponed.

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Two newly announced June dates go some way to alleviating the recent drought in advisory committee meetings outside oncology. Both gatherings of committees under the Office of Neuroscience promise fireworks in a different way.

Key Takeaways

Upcoming FDA Advisory Committee Meetings

  • 22 May: The Oncologic Drugs Advisory Committee’s Pediatric Subcommittee will discuss implementation of the 2017 FDARA legislation’s pediatric provisions.

On 4 June, the Psychopharmacologic Drugs Advisory Committee will, for the first time, evaluate an NDA for a psychedelic-assisted therapy...

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