News AnalysisRegulatory News FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claimsClinical benefit will not be considered for approval, FDA says September 25, 2026Vol.52 No.35By Jacquelyn Cobb and Sara Willa Ernst
Perspective When did stage 3B lung cancer become “early stage”? September 25, 2026Vol.52 No.35By Raja M. Flores
Cancer Policy At confirmation hearing, Heidi Overton sidesteps questions about FDA regulation of fruit-flavored vapes September 25, 2026Vol.52 No.35By Sara Willa Ernst
Cancer Policy HHS issues direct final rule to reduce reliance on animal testing September 25, 2026Vol.52 No.35By Claire Marie Porter
Drugs & Targets FDA approves Lyrfigtu for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma September 25, 2026Vol.52 No.35
Drugs & Targets FDA approves belzutifan in combination with lenvatinib for advanced RCC with a clear cell component September 25, 2026Vol.52 No.35
Drugs & Targets FDA grants Priority Review to perioperative IMFINZI + enfortumab vedotin for muscle-invasive bladder cancer September 25, 2026Vol.52 No.35
Cancer Policy FDA’s expedited IND pilot aims to shorten the timeline between drug development and first-in-human clinical trials September 18, 2026Vol.52 No.34
Drugs & Targets FDA approves imlunestrant + abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer September 18, 2026Vol.52 No.34
