FDA's CDER unit issues 2021 new drug approvals report

The US Food and Drug Administration’s Center for Drug Evaluation and Research has issued its report,  Advancing Health Through Innovation: New Drug Therapy Approvals, which shows that 50 novel drugs were approved through the whole of 2021; including the first KRAS inhibitor for cancer and the first anti-amyloid antibody for Alzheimer’s disease. As in the past, the new drugs approved last year span many areas of medicine and disease areas.

The FDA’s approval count last year was in line with recent trends, despite the continued impact of COVID-19. The agency’s CDER approved 50 novel therapeutics in 2021, down from 53 in 2020. The five-year average is 51 drugs per year, while a decade ago, it was 24 drugs per year. Most drugs were also approved in the U.S. before any other country.

This listing below does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2021.