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 ...

Among cancer drugs with accelerated approval, those backed with the strongest evidence tended to require less time to get ...

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

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 ...

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

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

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

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

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 ...

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 ...

Atrasentan reduced urine protein-to-creatinine ratio by 38% compared with 3% for placebo at week 36. The Food and Drug Administration (FDA) has granted accelerated approval to Vanrafia ...