Posted by Michael Wonder on 26 Dec 2022
Junshi Biosciences and Coherus share update on the FDA review of the biologics license application for toripalimab as treatment for recurrent or metastatic nasopharyngeal carcinoma
25 December 2022 - FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the biologics license application.
Shanghai Junshi Biosciences and Coherus BioSciences today announced that the companies have not received an action letter from the US FDA regarding the biologics license application for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma by the PDUFA date of 23 December 2022.
