Posted by Michael Wonder on 21 Dec 2022
FDA grants fast track to Edesa Biotech's ARDS drug candidate
20 December 2022 - Edesa Biotech has received fast track designation from the US FDA for its monoclonal antibody candidate, EB05.
Approval of the company's application follows favourable Phase 2 results from an international Phase 2/3 study of EB05 in hospitalised COVID-19 patients with acute respiratory distress syndrome, a severe form of respiratory failure characterised by widespread inflammatory injury to the lungs.
