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To view or add a comment, sign in FDA grants traditional approval to Novartis' Fabhalta (Iptacopan), an an oral Factor B inhibitor to slow the decline of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) recognised as one of the most common autoimmune kidney diseases, with roughly 25 newly diagnosed cases per million people annually worldwide This first-in-class complement inhibitor received the approval through a priority review process after its initial accelerated approval in August 2024 for reducing proteinuria in primary IgAN To view or add a comment, sign in One in five people in the UK have fatty liver disease

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The regulatory landscape is shifting

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