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

Novartis has claimed accelerated approval from the FDA for a second ... are at risk of rapid disease progression, making it the first complement inhibitor for the rare kidney disease.

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 ...

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.

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 ...

Patients will be able to get a 10 minute injection of the Roche drug, instead of an hours-long infusion. Novartis already has ...

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 ...

The Food and Drug Administration (FDA) has granted full approval to Filspari ® (sparsentan) to slow kidney function decline in adults with primary immunoglobulin A (IgA) nephropathy who are at risk ...

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

Bayer’s Kerendia, at the center of a $3 billion sales forecast, reduced the risk of cardiovascular death and heart failure in ...

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 ...

Filspari had received an "accelerated approval" from the FDA in February 2023, to reduce proteinuria in adults with primary ...