At least 9 PDUFA dates on deck in September: Data Byte

The month of September has at least nine PDUFA dates for candidate therapies, five of which have been granted priority review by FDA.

FDA approved the first of these, an sBLA to extend the label of Opdivo nivolumab to the adjuvant setting for urothelial cancer, on Aug. 19. It’s the first approval for adjuvant treatment of patients with high risk urothelial cancer. The PD-1 inhibitor was approved to treat locally advanced or metastatic urothelial cancer in 2016...