FDA advisers back GRAIL’s Galleri test; final decision remains pending
An FDA advisory committee voted in favor of the benefit-risk profile of GRAIL ($GRAL)’s Galleri multicancer early-detection test for adults aged 50 and older. The benefit-risk vote was seven to two, with one abstention. Panel members unanimously supported safety, while the effectiveness assessment passed six to four, showing that the individual questions attracted different levels of support. The recommendation moves the application forward but does not constitute FDA approval. The agency is not
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