Keeping Track: US FDA Issues Alzheimer’s Breakthrough Designations, Arimoclomol CRL, Rinvoq Delays
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Keeping Track: GSK Earns New Claims For Shingrix, Nucala; Keytruda’s TNBC Label Grows; CRL For Iterum
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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.
Safety appears balanced between the drug and placebo arms in upadacitinib’s third Phase III trial in ulcerative colitis, but there were low numbers of MACE and there are lingering safety concerns about the JAK class overall.