Novartis Secures Third FDA Approval For Its Kidney Disease Portfolio In One Year
FDA grants accelerated approval to Novartis' Vanrafia for IgA nephropathy, with Phase 3 data in 2026 expected to support ...
Fierce Pharma5h
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 ...
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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 ...
Fierce Pharma13d
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 ...
Novartis13d
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) ...
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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 ...
Managed Healthcare Executive1h
FDA Grants Accelerated Approval to Vanrafia for IgAN, a Rare Kidney Disease
Vanrafia reduces proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). It has a wholesale acquisition cost ...
Pharmaceutical Technology on MSN10h
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 ...
BioSpace13d
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.
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 ...
WGHP13d
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 ...