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FDA Approves Expanded Use Of Novartis' Rare Disease Drug Fabhalta For Kidney DiseaseOn 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 TreatmentNovartis 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.
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 ...
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