FiercePharma4h
Vanrafia, 2nd drug in Novartis' IgAN troika, crosses FDA finish line in payday for Chinook investors
Fabhalta a few days ago became the first FDA-approved agent for complement 3 glomerulopathy (C3G). Travere has recently filed ...
GlobalData on MSN1d
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 ...
Zacks.com on MSN1d
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.
pharmaphorum13d
Fabhalta is first FDA-approved therapy for rare disease C3G
Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting ...
Fierce Pharma13d
Novartis snags FDA nod for Fabhalta in another kidney disease but leaves room for rival Apellis
Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...
Novartis13d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
Basel, March 20, 2025 – Novartis today announced that oral Fabhalta ® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G) ...
PMLive9d
Novartis’ Fabhalta granted FDA approval to treat ultra-rare kidney disease C3G
Novartis’ oral Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first treatment for ...
Nasdaq2d
Apellis Pharma Says FDA Granted Priority Review To SNDA For Empaveli For C3G And Primary IC-MPGN
for empaveli for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), severe and rare kidney diseases. The Prescription Drug User ...
Managed Healthcare Executive13d
FDA Approves Novartis’ Oral Fabhalta as First Treatment for C3G
The FDA on Thursday approved Fabhalta (iptacopan) to treat complement 3 glomerulopathy (CG3), a progressive, ultrarare kidney ...
Seeking Alpha2d
Apellis Announces FDA Acceptance and Priority Review of the Supplemental New Drug Application for EMPAVELI® (pegcetacoplan) for C3G and Primary IC-MPGN
“Efficacy is critically important when treating C3G and IC-MPGN given the high risk of progression to kidney failure. As a disease-modifying therapy, EMPAVELI has the potential to make a life ...
Yahoo Finance13d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) - the first and only treatment approved in C3 glomerulopathy (C3G)
"C3G is a debilitating disease often affecting young people, impacting many aspects of their physical and emotional health, and our previous treatment options came with significant challenges ...