CODX - BioCryst NDA Accepted And Other News: The Good Bad And Ugly Of Biopharma
BioCryst Pharmaceuticals Goes Ahead with FDA Marketing Application
BioCryst Pharmaceuticals (BCRX) reported that the FDA has accepted its marketing application for review. The application pertains to its drug candidate Berotralstat designed to prevent hereditary angioedema attacks. The PDUFA date for the drug has been set at December 3, 2020. According to the NDA filing acceptance letter issued by the FDA, the agency is not planning to hold any advisory committee meeting for discussing the NDA.
Earlier this month, the company had submitted a new drug application for Berotralstat with the Japanese Pharmaceuticals and