C21 · Pharmaceuticals · US
New drug approvals in United States
United States: 46 (novel drug approvals, 2025), −8.0% on 2024. It ranks #1 of 5 countries for new active substance approvals (2025).
- 46 Latest · 2025
- −8.0% vs 2024
- #1of 5 countries · 2025
- 15Records · 13 measures
Annual · 2 publishers · Next period 2026
Novel drug approvals in United States
Novel drug approvals
United States, 2024 to 2025
Every record
15 records across 13 measures, newest first within each. Each period opens its record and quote.
How United States ranks
- New active substance approvals by country #1 of 5 · 50 · 2025
Frequently asked questions
What is the latest new drug approvals figure for United States?
United States: 46 novel drug approvals in 2025, −8.0% on 2024.
How does United States rank?
#1 of 5 for new active substance approvals (2025, 50).
Where does the United States data come from?
15 records from 4 documents by FDA, CIRS. Each figure links to its record and the sentence it was read from.
Cite this page
Free to reuse under CC BY 4.0 with attribution to StatOrigin and the original publisher.
StatOrigin. (2026). New drug approvals in United States [Data set]. Retrieved September 29, 2026, from https://statorigin.org/statistics/new-drug-approvals/united-states
"New drug approvals in United States." StatOrigin, 2026, https://statorigin.org/statistics/new-drug-approvals/united-states. Accessed 29 Sep. 2026.
StatOrigin. "New drug approvals in United States." Data set, 2026. Accessed September 29, 2026. https://statorigin.org/statistics/new-drug-approvals/united-states.
@misc{statorigin_new_drug_approvals_united_states_2026, title = {New drug approvals in United States}, author = {{StatOrigin}}, year = {2026}, url = {https://statorigin.org/statistics/new-drug-approvals/united-states}, note = {Data set. Accessed 2026-09-29} }