A Travere Therapeutics drug for a rare disease that can progress to kidney failure has converted its status to full FDA approval ... them a Novartis drug recently awarded accelerated approval.

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.

Travere Therapeutics TVTX announced that the FDA ... approval to its oral non-immunosuppressive drug Filspari (sparsentan) in IgA nephropathy (IgAN) indication, a rare progressive kidney disease.

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.

The submission, made on Tuesday, aims to secure approval for OLC's use in treating hyperphosphatemia in patients with chronic kidney disease ... for the drug's potential launch. The FDA has ...

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 ...

LOS ALTOS, Calif. - Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a clinical-stage biotechnology company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ...