The FDA has published its first-ever guidance document on clinical trials with psychedelic drugs, an emerging treatment category for psychiatric and substance use disorder
Intercept Pharma has conceded defeat in its battle to get obeticholic acid (OCA) approved as a treatment for non-alcoholic steatohepatitis (NASH) after the FDA rejected it
F2G’s attempt to end a two-decade drought in novel therapies for invasive fungal infections has hit a hurdle after the FDA said it was unable to approve its olorofim candi
GSK won’t be hearing from the FDA this month about its marketing application for momelotinib as a treatment for myelofibrosis patients with anaemia after all.
The first full regulatory approval for an amyloid-targeting therapy for Alzheimer’s disease could come within a month, after an expert panel voted 6 to 0 in favour of Eisa
Eisai has filed for approval of its Alzheimer’s disease therapy Leqembi in South Korea, just ahead of an FDA advisory committee meeting that has raised confidence that the
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.