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

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

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

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.

FDA grants full approval to Travere's Filspari, expanding treatment for IgA nephropathy, a rare kidney disease affecting ...

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

Staff reviewers at the U.S. Food and Drug Administration said on Wednesday a confirmatory trial did not show the ...

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 ...

Returning to Boston this December, the 4th annual Rare & Genetic Kidney Disease Drug Development Summit will unite 30+ experts speakers including Novartis, FDA, XORTX Therapeutics, Walden Biosciences, ...

Independent advisers to the U.S. Food and Drug Administration voted on Friday against confirmatory trial data for Intercept Pharmaceuticals' liver disease drug, putting into question the treatment's ...

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