Spruce Biosciences has put out new shoots, snapping up rights to a former BioMarin rare disease candidate and outlining plans ...

Ensuring timely completion of post-approval studies and enforcing appropriate regulatory actions based on negative trial results is necessary to minimize patient exposure to ineffective and ...

The FDA has granted accelerated approval to Novartis’ Vanrafia for adults with primary immunoglobulin A nephropathy (IgAN).

The approval was granted on an accelerated basis. The candidate got approval under the brand name Vanrafia. IgAN is a progressive, rare kidney disease. Approximately 50% of patients with ...

Ipsen and its fellow French partner Genfit are competing with Intercept and Advanz’s Ocaliva, which was approved in 2016 and ...

Novartis ( NYSE: NVS) said on Thursday that it received US FDA's accelerated approval for Vanrafia as a treatment for adults ...

Richard Lafayette, MD, FACP, Stanford University Medical Center, explains the significance of this second approval in a month ...

Opens in a new tab or window A report showed that in cancer drug indications that received FDA accelerated approval, demonstrated high clinical benefits correlated with shorter times to subsequent ...

Novartis (NVS) “announced the FDA has granted accelerated approval for Vanrafia, or atrasentan, a potent and selective endothelin A receptor ...

The US Food and Drug Administration (FDA) has granted accelerated approval to Novartis’ Vanrafia, a treatment aimed at decreasing proteinuria in adults with primary immunoglobulin A nephropathy ...