The Food and Drug Administration expanded the approval of Kisqali, a drug for metastatic breast cancer, to also treat ...
The drug is approved in combination with an aromatase inhibitor as adjuvant therapy for breast cancer patients at high risk of recurrence.
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® ...
A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. | A year after missing on a trial ...
In the meantime current gene therapies remain expensive and challenging to scale up because each patient’s batch of cells has ...
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.
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.
The regulator’s decision expands the drug’s indication to cover all patients who are at risk of disease progression The US Food and Drug Administration (FDA) has granted full approval to Travere ...
The FDA has approved a groundbreaking new drug to slow the progression of Alzheimer's disease in its early stages, offering ...
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.