New Drugs Approved in 2021

In 2021, the US Food and Drug Administration (FDA) approved 50 novel drugs.1 Several expedited review pathways, including accelerated approval, priority review, fast track, and breakthrough therapy, allow for approval processes that allow drugs to be available earlier than had they undergone review in the traditional pathway. Ultimately, this allows for expedited approval and availability of drugs that treat a serious condition or fill an unmet medical need. Of the novel drug approvals in 2021, 37 of the 50 (74%) drugs were processed via one of the expedited review pathways, and 26 of the 50 (52%) were approved for treatment of a rare disease.
Source: The American Journal of Medicine - Category: General Medicine Authors: Tags: Review Source Type: research