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 ...

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

Novartis’ Vanrafia (atrasentan) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat ...

Richard Lafayette, MD, FACP, Stanford University Medical Center, explains the significance of this second approval in a month ...