Apellis Pharmaceuticals has announced US FDA acceptance of the supplemental new drug application (sNDA) and the granting of ...

The FDA accepts Apellis' sNDA seeking label expansion of Empaveli to treat two rare kidney diseases for review under the Priority Review pathway.

When Novartis bought kidney disease biotech Chinook Therapeutics in 2023 for $3.2 billion upfront, the deal included a ...

“Efficacy is critically important when treating C3G and IC-MPGN given the high risk of progression to kidney failure. As a disease-modifying therapy, EMPAVELI has the potential to make a life ...

for empaveli for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), severe and rare kidney diseases. The Prescription Drug User ...

Vanrafia reduces proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). It has a wholesale acquisition cost ...

The approval of iptacopan in reducing proteinuria in adult patients with native kidney C3G was based on data from the randomized, double-blind, placebo-controlled, phase 3 APPEAR-C3G trial.

Apellis' Empaveli receives FDA Priority Review for rare kidney diseases C3G and IC-MPGN. Phase 3 data show strong efficacy in proteinuria reduction.

Vanrafia (atrasentan) is the first drug in the selective endothelin A receptor antagonist (ERA) class to be cleared in the US ...

The supplemental New Drug Application for the C3G and IC-MPGN indications is supported by data from the phase 3 VALIANT study.

Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted and granted Priority Review designation ...

IgAN is a progressive, rare kidney disease in which the immune system attacks the kidneys, often causing glomerular inflammation and proteinuria.