GRAIL Announces FDA Advisory Committee Meeting to Review Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test
GRAIL announced that the FDA's Molecular and Clinical Genetics Panel is scheduled to meet on Sept. 23, 2026, to review the Premarket Approval application for the Galleri multi-cancer early detection blood test. The PMA submission is supported by data from 25,490 participants in the PATHFINDER 2 study and over 70,000 participants from the intervention arm of the NHS-Galleri trial.
Key figures
- Drug Name
- Galleri
- Meeting date
- Sept 23, 2026
- Nhs galleri participants
- 70000
- Pathfinder2 participants
- 25490
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