Renal & Urology News11h
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.
MPR13h
Pegcetacoplan Gets Priority Review for Two Rare Kidney Diseases
The supplemental New Drug Application for the C3G and IC-MPGN indications is supported by data from the phase 3 VALIANT study.
The Financial Express1d
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 accepts priority review of Apellis’ Empaveli sNDA for kidney diseases
Apellis Pharmaceuticals has announced US FDA acceptance of the supplemental new drug application (sNDA) and the granting of ...
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.
The Manila Times3d
Eton Pharmaceuticals Out-Licenses International Rights to Increlex®
Esteve will license the ex-U.S. rights for up to ten years and will also be receiving an option to acquire the international ...
Apellis announces FDA acceptance, priority review of sNDA for EMPAVELI
Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted and granted Priority Review designation ...