Keeping Track: A Quintet Of Novel Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
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When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
After Pfizer saw increased risks in a surveillance study of Xeljanz, three other products have also seen their user fee dates pushed back; if FDA were to convene an expert panel, it could lead to more consistent labeling across the class, as requested in a recent citizen petition.
ViiV Healthcare’s “last resort” HIV drug, fostemsavir, is one of 16 new medicines that are up for an opinion by the European Medicines Agency on whether they should be authorized for use across the EU.