A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. | A year after missing on a trial ...

Travere Therapeutics TVTX announced that the FDA granted full approval to its oral non-immunosuppressive drug Filspari ...

Novartis’ Fabhalta (iptacopan) has been granted accelerated approval by the US Food and Drug Administration (FDA) to reduce excess protein in the urine (proteinuria) of patients with the rare kidney ...

The company had focused its resources on Filspari’s launch in IgAN after the US FDA snubbed the therapy in another rare ...

Reuters Health Information, August 07, 2024 US FDA Approves Novartis' Kidney Disease Drug The U.S. Food and Drug Administration has approved the use of Novartis' drug to reduce excess protein in ...

Looking to build on the success of Chinook Therapeutics, founded by Versant in 2019 and acquired by Novartis last year, the ...

progressive kidney disease and a leading cause of kidney failure due to glomerular disease. The FDA early last year had granted conditional approval of the drug, subject to confirmatory study results.

The PDUFA date refers to the deadline set by the US Food and Drug Administration for reviewing drug applications.

Novartis’ $3.2 billion deal for Chinook Therapeutics gave the Swiss Big Pharma such a taste for kidney disease ... own iptacopan scored FDA approval in IgAN. That drug, marketed as Fabhalta ...

The common, but serious, complication of chronic kidney disease is often seen in patients on hemodialysis. Upacicalcet is already approved for SHPT in Japan, where the drug “performed ...

Atrasentan hydrochloride is a small molecule commercialized by Novartis, with a leading Pre-Registration program in IgA Nephropathy (Berger's Disease).

The FDA has approved axatilimab-csfr (Niktimvo) for treating adults and children with chronic graft-versus-host disease who have progressed on at least 2 prior treatments. The FDA approved ...