FDA granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery. “Atezolizumab was granted Priority Review designation based...
Last week, Richard Pazdur was named to the position of director of FDA’s Center for Drug Evaluation and Research. Much has been written about how Pazdur, with nearly a three-decade long career at the agency, represents a stabilizing choice for FDA as it faces inner and outer turmoil.
