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

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

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

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

Apellis and Sobi's Aspaveli application for C3G and IC-MPGN treatment validated by the EMA, addressing rare kidney diseases. Apellis Pharmaceuticals and Sobi announced that the European Medicines ...

Submitted a supplemental new drug application (sNDA) for approval of EMPAVELI for C3G and primary IC-MPGN; U.S. launch anticipated in 2H 2025, if approved On track to initiate two Phase 3 trials of ...

"C3G and IC-MPGN are severe and life-threatening kidney conditions, often leading to kidney failure and requiring a kidney transplant or dialysis for life," said Lydia Abad-Franch MD, Head of R&D ...

"C3G and IC-MPGN are severe and life-threatening kidney conditions, often leading to kidney failure and requiring a kidney transplant or dialysis for life,” said Lydia Abad-Franch, M.D., head of R&D ...