US FDA New Drug Approvals 2019 Snapshot

Annual numbers of new molecular entities (NMEs) and biologics license applications (BLAs) approved by the FDA’s Center for Drug Evaluation and Research (CDER). Approvals of products such as vaccines and gene therapies by the Center for Biologics Evaluation and Research (CBER) are not included in this drug count.

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CDER approvals by selected therapeutic areas 2014-2018 average in comparison to 2019.

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