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Keeping Track Of US FDA Decisions: COVID-Induced Complete Response Letter For Contepo; Safety Sinks Abicipar Pegol; Approvals For Fintepla and Gimoti

Executive Summary

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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Novartis' Inclisiran Grounded In The US By FDA Inspection Restrictions

The US FDA issued a complete response letter for inclisiran, delaying the launch of the RNAi-based PCSK9 inhibitor for high cholesterol.

US FDA Picks Up The Pace Of Complete Response Letters Over June And July

The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.

Allergan Declines To Confirm Abicipar Pegol Fate

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.

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