The number of FDA approvals in 2022 was the second lowest since 2014, when the annual number of approvals first spiked substantially compared with the previous decade (Fig. 1). The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research approved 43 new therapeutic drugs (NTDs; see Fig. 1 for the definition), including the second COVID-19 vaccine to secure full FDA approval, Moderna’s Spikevax. This count is below the average of 51 NTDs per year for 2014–2021, perhaps partly due to pandemic-related and other macroeconomic stressors, including the impact of COVID-19 on clinical trials and resource constraints at biopharma sponsors and the FDA.
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Competing Interests
The authors of this article are employees of The Boston Consulting Group (BCG), a management consultancy that works with the world's leading biopharmaceutical companies. The research for this specific article was funded by BCG's Health Care practice.
