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.
Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US.
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
AstraZeneca's antibody cocktail for COVID-19, now called Evusheld, has become the first drug in the class to be authorised for prevention of infection by the US FDA.
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.