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FDA Still Won’t Approve Galleri After Advisory Panel Vote

By Drooid · Oct 7, 2026, 4:03 PM UTC · How we work

Summary

Story summary

U.S. FDA has not approved Grail’s Galleri blood test following the advisory panel’s recommendation.
The panel voted unanimously on safety, 6-4 on effectiveness, and 7-2 that benefits outweigh risks.
The Medicare Multi-Cancer Early Detection Screening Coverage Act mandates Medicare coverage after FDA approval.
A UK NHS trial of Galleri showed no reduction in late-stage cancer, missing its primary endpoint.

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Story summary

U.S. FDA has not approved Grail’s Galleri blood test following the advisory panel’s recommendation.
The panel voted unanimously on safety, 6-4 on effectiveness, and 7-2 that benefits outweigh risks.
The Medicare Multi-Cancer Early Detection Screening Coverage Act mandates Medicare coverage after FDA approval.
A UK NHS trial of Galleri showed no reduction in late-stage cancer, missing its primary endpoint.