The approval is supported by a prespecified interim analysis from the ongoing, randomised Phase III ALIGN trial.

The FDA granted accelerated approval to atrasentan (Vanrafia) for the reduction of proteinuria in adults with primary ...

The Food and Drug Administration (FDA) has granted accelerated approval to Vanrafia ® (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid ...

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

The U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval for Novartis AG’s (NYSE:NVS) Vanrafia ...

Vanrafia reduces proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). It has a wholesale acquisition cost ...

The U.S. Senate last week confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the Food and Drug ...

Ex-vaccine regulator Peter Marks promoted "ineffective therapy that gave patients false hope, eroded trust in the regulatory ...

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 ...

Researchers analyzed pivotal and confirmatory trial characteristics, outcomes, and safety data for 102 cancer drug ...

When Novartis bought kidney disease biotech Chinook Therapeutics in 2023 for $3.2 billion upfront, the deal included a ...

Novartis’ Vanrafia (atrasentan) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat ...