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Novartis gets FDA nod for second of three IgAN drugs
Vanrafia (atrasentan) is the first drug in the selective endothelin A receptor antagonist (ERA) class to be cleared in the US for IgAN, a disease characterised by the accumulation of antibodies in the ...
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Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
Basel, March 20, 2025 – Novartis today announced that oral Fabhalta ® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G) ...
Fierce Pharma12d
Novartis snags FDA nod for Fabhalta in another kidney disease but leaves room for rival Apellis
Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...
FDA grants accelerated approval to Novartis’ Vanrafia for IgAN
The approval is supported by a prespecified interim analysis from the ongoing, randomised Phase III ALIGN trial.
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Fabhalta is first FDA-approved therapy for rare disease C3G
Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting ...
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APLS' Empaveli sNDA for 2 Rare Kidney Diseases Gets FDA Priority Tag
Apellis Pharmaceuticals APLS announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the ...
FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease
Novartis' Fabhalta receives FDA approval for C3 glomerulopathy, expanding its kidney disease portfolio as global regulatory ...
BioSpace12d
Novartis’ Fabhalta Approved as First Therapy for Rare Kidney Disease
This is the third indication for Fabhalta after Novartis won FDA approval of the small molecule in paroxysmal nocturnal hemoglobinuria and primary immunoglobulin A nephropathy.
Managed Healthcare Executive12d
FDA Approves Novartis’ Oral Fabhalta as First Treatment for C3G
The FDA on Thursday approved Fabhalta (iptacopan) to treat complement 3 glomerulopathy (CG3), a progressive, ultrarare kidney ...
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Novartis receives third FDA approval for oral Fabhalta® (iptacopan) - the first and only treatment approved in C3 glomerulopathy (C3G)
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 ...