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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Moving away from its earlier hospital-based focus with the novel antibiotic, Nabriva also thinks selling Merck & Co.’s Sivextro will provide complementary business.
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.