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.

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

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

Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting a green light in ultra-rare kidney disease C3 glomerulopathy (C3G).

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

Updated results from the APPEAR-C3G trial – reported at the American Society of Nephrology (ASN) Kidney Week congress in San Diego over the weekend – showed that Fabhalta (iptacopan ...

The development of advanced radiotherapy technologies has, in turn, resulted in an increased complexity of operations. Also, a high level of accuracy is needed at every step of the process to achieve ...

The development of advanced radiotherapy technologies has, in turn, resulted in an increased complexity of operations. Also, a high level of accuracy is needed at every step of the process to achieve ...

"This approval of Fabhalta is historic for the entire C3G community as now, for the first time, we have a therapy that is believed to treat the underlying cause of the disease, providing the potential ...

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