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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

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

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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.

Stacked User Fee Calendar Puts Another Record-Setting Year For US FDA Novel Approvals Within Reach

With goal dates for almost 40 novel drugs and biologics coming up in the second half of 2020 after a record number of first half approvals, even the pandemic looks unlikely to prevent another solid year for innovative drugs at US FDA.

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