The FDA has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.

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

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.

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 ...

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 ...

Novartis AG (NYSE: NVS) recently announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to ...

Novartis’ oral Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first treatment for ...

The FDA has approved Novartis’ Fabhalta (iptacopan) as the first and only treatment for C3 glomerulopathy (C3G). Previously, patients with C3G were forced to rely on supportive care and broad ...

The U.S. Food and Drug Administration (FDA) has announced a series of critical updates this week, reflecting its ongoing commitment to advancing public health and medical safety.