Posted by Michael Wonder on 13 Jul 2023
Aridis’ AR-301 monoclonal antibody is among the first biologics to receive FDA’s qualified infectious diseases product designation
12 July 2023 - QIDP designation for biologics provides FDA priority review status.
Aridis Pharmaceuticals today announced that the US FDA has granted qualified infectious disease product designation under the Generating Antibiotic Incentives Now (GAIN) Act for AR-301, a fully human IgG1 monoclonal antibody currently in Phase 3 clinical development as an adjunctive therapy for pneumonia caused by gram positive Staphylococcus aureus in critically ill hospitalised patients.
