Keeping Track Of US FDA Decisions: COVID-Induced Complete Response Letter For Contepo; Safety Sinks Abicipar Pegol; Approvals For Fintepla and Gimoti
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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The US FDA issued a complete response letter for inclisiran, delaying the launch of the RNAi-based PCSK9 inhibitor for high cholesterol.
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.
There is speculation that it is the end of the road for abicipar pegol but Allergan has declined to say whether this is the case for the product that has been in development for wet AMD.