FDA Review Of Novartis' Entresto Shows Agency's Practical Side
Pivotal trial of Novartis' sacubitril/valsartan duo in heart failure did not conform to FDA's combination policy, but agency ultimately valued its mortality effect over statistical correctness.
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Keeping Track: Terlipressin Falls Short Of US FDA Approval; Novel NDAs From Pfizer And Apellis; New BTDs For Sanofi, BeyondSpring
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.