Pink SheetSanthera Pharmaceuticals could soon find out whether its Duchenne muscular dystrophy drug vamorolone will be recommended for EU marketing approval by the European Medicines Agency, paving the way for
Pink SheetSanthera ’s Agamree (vamorolone) for the rare disease Duchenne muscular dystrophy (DMD) is among seven new drugs the European Medicines Agency has said should be approved for marketing in the EU. The
Pink SheetThe US FDA approved six novel agents over the first three weeks of May, representing the work of six different review different divisions. The new approvals account for a little more than a quarter of
Pink SheetA staggering 16 novel agents have user fee goal dates in the next month, carrying the potential to transform US FDA’s approval narrative for 2023. The pending novel agents outweigh the number of other