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FDA Approves Expanded Use Of Novartis' Rare Disease Drug Fabhalta For Kidney Disease
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 ...
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FDA Approves Novartis Drug for Rare Kidney Disease Treatment
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 ...
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Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels
An ultra-rare kidney disease that can become life-threatening now has its first FDA ... the drug expanded its approval to include the rare autoimmune kidney disease IgA nephropathy. Novartis ...
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Novartis gets FDA accelerated approval for kidney disease treatment
Novartis (NYSE:NVS) said on Thursday that it received US FDA's accelerated approval for Vanrafia as ... which plays a role in kidney disease progression. By doing so, it helps reduce proteinuria ...
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Novartis Secures Third FDA Approval For Its Kidney Disease Portfolio In One Year
Also Read: FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals ... with previously reported data. This is Novartis’s third U.S. approval for its kidney disease portfolio in the last ...
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FDA Grants Accelerated Approval to NVS Kidney Disease Drug
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 ...
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FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease
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 ...
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FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease
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 ...