Among cancer drugs with accelerated approval, those backed with the strongest evidence tended to require less time to get full approval, researchers found. A study found that of 102 cancer drug ...

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

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 ...

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

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 ...

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 ...

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 ...