Novel drug approvals
RecordSTO-FYPH5BNZDF-28G5Z8B3HW-EGC64Z
United States · 2025
Novel drug approvals in the United States were 46 in 2025 (FDA).
New drug approvals in United States: every year, the rank and how it is measured
- Publisher
- FDA
- Authority tier
- T1 Official
- Locator
- FDA Novel Drug Therapy Approvals for 2025
- Retrieved
- 17 Sep 2026
- Status
- Verified
What the source says
In 2025, CDER approved 46 new drugs never before approved or marketed in the U.S., known as “novel” drugs.
Checked: the figure 46is stated in this passage. If it does not match, the extraction is wrong and we want to know.
Cite this figure
APA
U.S. Food and Drug Administration. (2025). Novel Drug Approvals for 2025. Retrieved September 17, 2026, from https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. Via StatOrigin, https://statorigin.org/stat/stat_FYPH5BNZDF28G5Z8B3HWEGC64Z
Other formats: MLA, Chicago, BibTeX
- MLA
- U.S. Food and Drug Administration. "Novel Drug Approvals for 2025." 2025, https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. Accessed 17 Sept. 2026 via StatOrigin, https://statorigin.org/stat/stat_FYPH5BNZDF28G5Z8B3HWEGC64Z.
- Chicago
- U.S. Food and Drug Administration. "Novel Drug Approvals for 2025." 2025. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. Accessed September 17, 2026. Cited from StatOrigin, https://statorigin.org/stat/stat_FYPH5BNZDF28G5Z8B3HWEGC64Z.
- BibTeX
- @misc{fda2025novelegc64z, author = {{U.S. Food and Drug Administration}}, title = {Novel Drug Approvals for 2025}, year = {2025}, howpublished = {StatOrigin, https://statorigin.org}, url = {https://statorigin.org/stat/stat_FYPH5BNZDF28G5Z8B3HWEGC64Z}, note = {Original source: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. Accessed September 17, 2026.} }
Data published under CC BY 4.0. The citation credits the original publisher and links to this permanent record.
Provenance and verification
Everything needed to check this number yourself, without taking our word for it.
Primary source
- Publisher
- U.S. Food and Drug Administration · homepage ↗
- Authority tier
- Tier 1 · Multilateral Official
- Report
- Novel Drug Approvals for 2025
- Type
- Press release
- Published
- —
- Locator
- FDA Novel Drug Therapy Approvals for 2025
- Retrieved
- 17 September 2026
- Link status
- Reachable (HTTP 200)
- Report licence
- See source
Verification
- Status
- Verified
- Review protocol
- Editorial review
- Checked on
- 17 September 2026
- Last revision
- 17 September 2026
- Permanent URL
- /stat/stat_FYPH5BNZDF28G5Z8B3HWEGC64Z