In 2025, ** novel drugs were approved by the Center for Drug Evaluation and Research (CDER). The number of new medicinal products entering the pharmaceutical market each year varies heavily: just over ** novel drugs were introduced in 2016, while about ** new products were approved in 2018.Â
Biopharma medicines in development
Many new drugs are being developed as of 2024, and that is especially true for the U.S. pharmaceutical industry with its high R&D intensity. As of the beginning of 2024, around new immunological anticancer products were in development worldwide. Additionally, nearly other anticancer drugs were in R&D phases.Â
Cost of drug development: then vs. now
Back in the 1970s, developing a pharmaceutical drug in the United States cost an estimated *** million U.S. dollars. Over the past few decades, such expenses have increased, reaching roughly *** billion U.S. dollars per drug in the 2000s and early 2010s. Back in 1990, around ** percent of the revenue generated by the U.S. pharmaceutical industry was spent on research and development for new medicines. In 2023, the percentage stood at ** percent.
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Food and Drug Administration. (January 24, 2026). Total number of novel drugs approved by CDER from 2008 to 2025 [Graph]. In ÌÇÐÄÆÆ½â°æ. Retrieved July 27, 2026, from /statistics/817534/annual-novel-drug-approvals-by-cder/
Food and Drug Administration. "Total number of novel drugs approved by CDER from 2008 to 2025." Chart. January 24, 2026. ÌÇÐÄÆÆ½â°æ. Accessed July 27, 2026. /statistics/817534/annual-novel-drug-approvals-by-cder/
Food and Drug Administration. (2026). Total number of novel drugs approved by CDER from 2008 to 2025. ÌÇÐÄÆÆ½â°æ. ÌÇÐÄÆÆ½â°æ Inc.. Accessed: July 27, 2026. /statistics/817534/annual-novel-drug-approvals-by-cder/
Food and Drug Administration. "Total Number of Novel Drugs Approved by Cder from 2008 to 2025." ÌÇÐÄÆÆ½â°æ, ÌÇÐÄÆÆ½â°æ Inc., 24 Jan 2026, /statistics/817534/annual-novel-drug-approvals-by-cder/
Food and Drug Administration, Total number of novel drugs approved by CDER from 2008 to 2025 ÌÇÐÄÆÆ½â°æ, /statistics/817534/annual-novel-drug-approvals-by-cder/ (last visited July 27, 2026)
Total number of novel drugs approved by CDER from 2008 to 2025 [Graph], Food and Drug Administration, January 24, 2026. [Online]. Available: /statistics/817534/annual-novel-drug-approvals-by-cder/