Posted by Michael Wonder on 28 Oct 2020
Astellas receives U.S. FDA fast track designation for ASP5354, an investigational near-infrared fluorescence imaging agent
28 October 2020 - Astellas Pharma announced today that the US FDA has granted fast track designation based on non-clinical and clinical data for the development of ASP5354, an imaging agent being investigated for intra-operative ureter visualisation in patients undergoing minimally invasive and open abdominopelvic surgeries.
The ASP5354 Fast Track designation is expected to facilitate development and potentially early clinical availability with faster reviews of the novel agent.
