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

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 ...

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

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 ...

Even further than what I have highlighted, it is expected to possibly be in a position to file a New Drug Application [NDA] under an Accelerated Approval pathway based on a surrogate endpoint ...

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

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

Positive feedback from the FDA and EMA has aligned the development timeline for potential accelerated approval in the US and Europe. The study's registrational Phase 1/2 status aims to complete ...

Novartis NVS obtains FDA approval of atrasentan, a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy ...

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 ...