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 Food and Drug Administration expanded the approval of Kisqali, a drug for metastatic breast cancer, to also treat ...

Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4/6 inhibitor adjuvant therapy1,2 Kisqali® ...

The drug is approved in combination with an aromatase inhibitor as adjuvant therapy for breast cancer patients at high risk of recurrence.

An FDA advisory committee has ... drugmaker's data on bardoxolone – a drug for kidney disease – did not show it is effective. Reata is seeking approval from the US regulator for bardoxolone ...

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.

In the meantime current gene therapies remain expensive and challenging to scale up because each patient’s batch of cells has ...

The FDA has approved a groundbreaking new drug to slow the progression of Alzheimer's disease in its early stages, offering ...