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

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 ...

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

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

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 ...

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.

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

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

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

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, ...

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