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Showing posts from January, 2022

2021 New Drug Approvals, By The Numbers

 Last week, the FDA's Center for Drug Evaluation and Research released it 2021 report of New Drug Therapy Approvals. The approvals are notable for the potential to provide a positive impact on patient care. The following infographic shows some of the more notable statistics from this year's report. According to the FDA, CDER approved 50 new drugs in 2021. The applications represented both new molecular entities under New Drug Applications or new therapeutic biologics under Biologics License Applications. In each case, the active ingredient or ingredients have never been approved in the U.S.  New drugs advance treatment options in heart, blood, kidney and endocrine disease; autoimmune, inflammatory and lung diseases; infectious disease; neurological and psychiatric disorders; cancer; and other orphan conditions. 98 percent of the approvals were granted within the Prescription Drug User Fee Act timeframes and nearly 90 percent were approved on the first cycle. The FDA credits thi