On Thursday, the FDA granted accelerated approval to Novartis AG’s (NYSE ... at risk of rapid disease progression. In December 2023, the FDA approved Fabhalta as the first oral monotherapy ...

Novartis NVS announced that the FDA has approved Fabhalta (iptacopan) for a third indication. The regulatory body approved the drug for the treatment of adults with C3 glomerulopathy (C3G) to ...

A Travere Therapeutics drug for a rare disease that can progress to kidney failure has converted its status to full FDA approval ... them a Novartis drug recently awarded accelerated approval.

This is Novartis’s third U.S. approval for its kidney disease portfolio in the last year. Fabhalta was granted FDA approval in C3 glomerulopathy in March 2025 and accelerated approval in IgAN in ...

Novartis NVS obtains FDA approval of atrasentan, a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy ...

The FDA approved Novartis' Fabhalta, making it the first and only treatment for adults with C3 glomerulopathy. Fabhalta showed sustained proteinuria reduction in Phase 3 trials, with effects seen ...

On Thursday, the U.S. Food and Drug Administration (FDA) approved Novartis ... This is the third US approval for Fabhalta and its second within the Novartis kidney disease portfolio since August ...