New Drug Approvals and Their Contract Manufacture – 2022 Edition

In 2021, the FDA approved 122 New Drug Applications (NDAs) and Biologics License Applications (BLAs), including new molecular entities (NMEs), biologics approved as BLAs through the Center for Biologics Evaluation and Research (CBER), and new formulations of older drugs. The overall number of approvals is like 2020; however, the total number of innovative NME cell/gene therapy and non-NME NDAs has risen since 2020. There were four NME cell/gene therapy approvals in 2021, the highest over the last decade. These include two cell therapies and two gene-modified cell therapies.