48 New Novel Drugs Approved by the FDA in 2019

The U.S. Food and Drug Administration (FDA) oversees and approves a wide range of medical products each year. Many approvals are for previously approved drugs for new indications. Others are for new molecular entities and new therapeutic biological products. Below is a list of new molecular entities and new therapeutic biological products approved by the agency’s Center for Biologics Evaluation and Research in 2019. The list does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved this year.