Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo.
Robert Califf looks set to take a second term as FDA commissioner after navigating a relatively placid two-hour confirmation hearing in the US Senate, with just a few ripples of discontent
Already scrambling to refile its obeticholic acid (OCA) drug for non-alcoholic steatohepatitis (NASH) after the FDA rejected it last year, Intercept Pharma was hoping for more luck in Europ
An FDA advisory committee has delivered a blow to Reata Pharma, after voting unanimously that the drugmaker's data on bardoxolone – a drug for kidney disease – did not show it is effective.
BeyondSpring's hopes of an early Christmas gift from the FDA were dashed today after the regulator said it was unable to approve the company's lead drug plinabulin as a treatment for low wh
With rumours growing that that ex-FDA head Robert Califf looks set to receive President Joe Biden's nomination to be the next FDA commissioner, at least one analyst thinks the appointment w