FDA Novel Drug Approvals

FDA Novel Drug Approvals in 2022

The FDA's Center for Drug Evaluation and Research (CDER) approved 37 novel drugs in 2022, including new molecular entities (NMEs) and new therapeutic biological products (BLAs). This notice summarizes these approvals and provides a link to the full report.

FDA Novel Drug Approvals in 2023

The FDA's Center for Drug Evaluation and Research (CDER) approved 55 novel drugs in 2023, representing new therapies not previously marketed in the U.S. The agency released a report detailing these approvals and their uses.

FDA Novel Drug Approvals 2024

The FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2024, representing new molecular entities never before marketed in the U.S. This notice provides a list of these approvals and links to detailed reports and drug information.

FDA Novel Drug Approvals 2025

The FDA's Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025, meaning they were new and never before marketed in the U.S. The agency has released a report detailing these approvals, including drug names, active ingredients, and their approved uses.

FDA Approves 5 New Novel Drugs in 2026

The FDA has announced the approval of five new novel drugs in 2026 for various medical conditions. These approvals include treatments for achondroplasia, hyperarginemia, schizophrenia, bipolar disorder, atopic dermatitis, and Menkes disease. The agency updated its list of novel drug therapy approvals.