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 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.
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.