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

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 ...

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 ...

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

Between 2013 and 2023, 81% of first-in-class drugs were approved under at least one of the FDA’s expedited programs (priority review, accelerated approval, fast track and breakthrough therapy), ...

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

Drugs demonstrating substantial benefits in confirmatory trials, including overall survival improvements, convert from accelerated to full approval in median 2.15 years vs 3.70 years for those ...

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 ...