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The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved a wide variety of safe and effective new therapies in 2022, even as our nation continues to face the COVID-19 pandemic.
In 2022, CDER approved 37 new drugs never before approved or marketed in the U.S., known as “novel” drugs, as noted in our annual New Drug Therapy Approvals report. We also approved drugs in new settings, such as for new uses and patient populations.
The 2022 approvals target many different disease areas. For example, we approved treatments for a range of infectious diseases, including COVID-19, HIV, smallpox, influenza, and H. pylori infection (a bacterial infection in the stomach). Also approved were therapies for two severe and progressive neurological conditions, amyotrophic lateral sclerosis and spinal muscular atrophy.
CDER approved drugs for a range of heart, blood, kidney, and endocrine disorders, including drugs for type 1 and 2 diabetes, anemia, kidney impairment, and chronic weight management. We also approved therapies for autoimmune, inflammatory, and lung diseases, such as inflammatory bowel disease, nutritional deficiencies, lupus nephritis, arthritis, eosinophilic esophagitis (a chronic inflammatory disorder), and psoriasis.
In oncology, approvals included treatments for lung cancer, prostate cancer, uveal melanoma (a rare cancer that develops in a part of the eye called the uvea), and types of breast cancer, among other kinds of cancers.
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