Basel, March 20, 2025 – Novartis today announced that oral Fabhalta ® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G) ...
Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...
Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting ...
Learn notable things about them and their makers. Novartis’s Fabhalta submission in C3G was based on a placebo-controlled Phase 3 test that evaluated the study drug alongside supportive care.
Apellis' Empaveli receives FDA Priority Review for rare kidney diseases C3G and IC-MPGN. Phase 3 data show strong efficacy in proteinuria reduction.
Novartis' Fabhalta receives FDA approval for C3 glomerulopathy, expanding its kidney disease portfolio as global regulatory ...
Novartis’ oral Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first treatment for ...
Novartis NVS announced that the FDA has approved Fabhalta (iptacopan) for a third indication. The regulatory body approved ...
2025 – Novartis today announced that oral Fabhalta ® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to ...
EAST HANOVER, N.J., March 20, 2025 /PRNewswire/ -- Novartis today announced that oral ... approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it ...
without whom this first FDA approval in C3G wouldn't have been possible," said Victor Bultó, President US, Novartis. "With this additional approval for Fabhalta – the second in kidney disease ...