The US FDA Rejects Sesen Bio’s Vicineum (oportuzumab monatox-qqrs) for the Treatment of BCG-Unresponsive NMIBC
Shots: The company has received the FDA’s CRL declining the approval of Vicineum’s BLA to treat BCG-unresponsive NMIBC The FDA has provided recommendations to conduct additional clinical/statistical data and analyses of roxadustat in addition to CMC issues related to a recent pre-approval inspection and product quality The company plans to meet with the FDA as […]