The EMA's human medicines committee has said it cannot approve Biogen and Eisai's Alzheimer's disease therapy Aduhelm, saying it was unconvinced by the data submitted for the drug.
Patients in Wales with a rare disease that causes epilepsy will be the first in the UK to get access to GW Pharma's cannabis-based medicine Epidyolex, after the drug was cleared for use by
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
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.