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

Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting ...

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

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.

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

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 ...

(RTTNews) - Apellis Pharmaceuticals, Inc. (APLS) Tuesday said that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the supplemental New Drug Application ...

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

EAST HANOVER, N.J. - Novartis (Market Cap: $223.4B), a pharmaceutical giant with robust financial health according to InvestingPro metrics, has announced the FDA approval of Fabhalta (iptacopan ...