FDA issues final kidney volume biomarker guidance

FDA released final guidance on the use of total kidney volume (TKV) as a biomarker to enrich clinical trials of therapies to treat autosomal dominant polycystic kidney disease (ADPKD) with a high risk of progressive renal decline. The agency issued draft guidance on the biomarker last year, and received no comments (see BioCentury Extra, Aug. 14, 2015). ...