Novartis has received traditional approval from the US Food and Drug Administration (FDA) for Fabhalta® (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.
Fabhalta is the first and only complement inhibitor approved for this indication and follows its accelerated approval in 2024 for reducing proteinuria in patients with primary IgAN. The approval was granted under the FDA’s priority review pathway - Read More.
Basel, Switzerland- Roche is one step closer to gaining FDA approval for Xolair® (omalizumab). The agency accepts its supplemental Biologics License Application (sBLA) un...
