Delcath Systems: FDA accepts NDA resubmission for Hepzato Kit

Delcath Systems announced that the U.S. FDA has accepted Delcath Systems’ new drug application resubmission for Hepzato Kit seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma. The FDA also communicated to Delcath that they consider the submission a complete class 2 response and the PDUFA date for the resubmission is August 14, 2023.