FDA Grants Accelerated Approval to Novartis’ Fabhalta for Primary IgA Nephropathy
Accelerated approval of Fabhalta for treating primary IgA nephropathy was based on positive results from the Phase III APPLAUSE-IgAN study.
August 17, 2026
Accelerated approval of Fabhalta for treating primary IgA nephropathy was based on positive results from the Phase III APPLAUSE-IgAN study.