On Thursday, the FDA granted accelerated approval to Novartis AG’s (NYSE ... at risk of rapid disease progression. In ...

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.

Novartis said it received accelerated approval from the U.S. Food and Drug Administration for a treatment to bring down elevated levels of protein in the urine of adults who have a rare kidney ...

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

The regulator’s decision expands the drug’s indication to cover all patients who are at risk of disease progression ...

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 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 ...

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

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 ...