New Drugs Approved in 2021

Abstract

In 2021, the US Food and Drug Administration (FDA) approved 50 novel drugs. Thirty-seven of the 50 (74%) novel drug approvals were reviewed and approved through an expedited review pathway, and 26 of the 50 (52%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2021.