US FDA’s Novel Approvals Peak Near Year-End, Analysis Of Last Decade Suggests

The Center for Drug Evaluation and Research’s novel approvals concentrated in August, November, and December, while January and June were the slowest months, according to a Pink Sheet analysis of 2014-2023 data.

statistical analysis
January and June are slow months for NME approvals. • Source: Shutterstock

August, November and December have been the most fruitful months of the year for novel drug approvals over the past decade, a Pink Sheet US Food and Drug Administration Performance Tracker analysis found.

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