Keytruda TNBC Approval Now More Likely, But Data Is Bad News For pCR Surrogate Endpoint
Merck unveiled event-free survival results for Keytruda in triple-negative breast cancer following failure earlier this year to gain approval on a surrogate endpoint.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
FDA’s use of advisory committees is at a historic low – as are the prospects of sponsors getting a positive outcome. Is it COVID? Or a more fundamental shift in how FDA uses its panels?
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