Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half

 
• By Bridget Silverman

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.

FDA first-half plunge
APPROVALS HAVE TAKEN A DIVE IN THE FIRST HALF OF THE YEAR, BUT SECOND-HALF NUMBERS TEND TO BE HIGHER. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

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