Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half
With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.