EU Accelerated Assessment Tracker
GSK secured accelerated assessment for dostarlimab at the European Medicines Agency but there was no such good news for Merck/AstraZeneca's selumetinib. MYR Pharmaceuticals' bulevirtide has reverted to standard review timelines.
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Setmelanotide, which is being developed to treat insatiable hunger and early-onset severe obesity in people with rare genetic disorders, was also recently submitted to the US regulator for approval.
New drugs from Eli Lilly, Pfizer, Janssen, GSK, Arvelle, BioCryst, Diurnal and Myovant are also among the latest products the European Medicines Agency is evaluating for potential pan-EU approval.
Companies are due to learn this week whether the European Medicines Agency will fast-track its review of their soon-to-be-filed EU marketing applications.