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Novartis Canada is pleased to announce that Fabhalta® (iptacopan capsules) is now available across Canada for adult patients ...
The FDA has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.
Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting a green light in ultra-rare kidney disease C3 glomerulopathy (C3G).
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First Drug Approved for Ultra-Rare Kidney DiseaseThe FDA approved iptacopan (Fabhalta) as the first treatment to reduce proteinuria in adults with complement 3 glomerulopathy (C3G), the agency announced Thursday. "C3G is a debilitating disease often ...
Morgan Stanley analyst Judah Frommer notes that Novartis (NVS) has received FDA approval for Fabhalta for C3G. The label comes with a few important restrictions/caveats that leave room for Apellis ...
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Zacks Investment Research on MSNAPLS' Empaveli sNDA for 2 Rare Kidney Diseases Gets FDA Priority TagApellis Pharmaceuticals APLS announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the ...
Vanrafia, 2nd drug in Novartis' IgAN troika, crosses FDA finish line in payday for Chinook investors
When Novartis bought kidney disease biotech Chinook Therapeutics in 2023 for $3.2 billion upfront, the deal included a ...
EAST HANOVER, N.J., March 20, 2025 /PRNewswire/ -- Novartis today announced that oral Fabhalta ® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of ...
Findings from the APPEAR-C3G trial showed a 35% reduction in 24-hour UPCR from baseline (primary endpoint) in the iptacopan group compared with the placebo group. The Food and Drug Administration ...
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