Renal & Urology News1d
Fabhalta Approved as First Treatment for C3 Glomerulopathy
The FDA has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.
Managed Healthcare Executive1d
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 ...
Managed Healthcare Executive1d
The ‘Healthy Immigrant Effect’ Is Alive and Well in Kidney Disease, Study Finds
Previous research has found that immigrants have lower rates of heart disease, diabetes, dementia and other chronic health ...
Fierce Pharma1d
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 ...
FDA Grants Accelerated Approval to NVS Kidney Disease Drug
Novartis strengthens its renal disease portfolio with accelerated approval of another drug for immunoglobulin A nephropathy.
pharmaphorum2d
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 ...
The Financial Express2d
Novartis gets USFDA nod for its therapy to treat Berger’s disease
IgAN is a progressive, rare kidney disease in which the immune system attacks the kidneys, often causing glomerular inflammation and proteinuria.
APLS' Empaveli sNDA for 2 Rare Kidney Diseases Gets FDA Priority Tag
The FDA accepts Apellis' sNDA seeking label expansion of Empaveli to treat two rare kidney diseases for review under the Priority Review pathway.
FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals
Apellis' Empaveli receives FDA Priority Review for rare kidney diseases C3G and IC-MPGN. Phase 3 data show strong efficacy in proteinuria reduction.