The approval is supported by a prespecified interim analysis from the ongoing, randomised Phase III ALIGN trial.
Novartis NVS obtains FDA approval of atrasentan, a potent and selective endothelin A (ETA) receptor antagonist, for the ...
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. 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 ...
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 ...
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 ...
After some high-profile crashes, the one-time biotech darling is inching toward success with its Hunter syndrome treatment, ...
Novartis’ Vanrafia (atrasentan) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat ...