Over time
United States over time. Forecasts are dashed with hollow markers; the underlying values are one click away under the chart.
Novel drug approvals
United States, 2024 to 2025
Every record
3 records · 1 region · 2024–2025. Each period links to its record: the value, its source evidence and original document.
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Quote any number, cite this page or a single record, and link to it anywhere.
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The data is published under CC BY 4.0, commercial use included. Credit StatOrigin and the original publisher (FDA); the chart files already carry that line.
- The source documents: the publisher's terms
Figures are facts read from the publishers' own documents. The documents themselves, their text and design, stay under each publisher's terms; follow the source links for those.
How this measure is built
- Definition
- Total number of novel drugs approved for the first time by a regulatory authority within a calendar year.
- Measure
- One slice of Drug approvals ( form: count, segment: novel ) . Total number of therapeutic drugs granted regulatory marketing approval. Region and period are columns on every record, not slices.
- Limitations
- Values are shown as published; StatOrigin does not revise, fill gaps or convert currencies.
- Verification
- Each value, unit, period and place was checked against its source evidence before publication. See the methodology and the corrections process.
Sources · 3 documents
| Document | Publisher | Published | Data points |
|---|---|---|---|
| Novel Drug Approvals for 2025 | FDA | — | 1 |
| CDER Brings Many Safe and Effective Therapies to Patients and Consumers in 2024 | FDA | — | 1 |
| Novel Drug Approvals for 2024 | FDA | — | 1 |
Other slices of drug approvals
- First-in-class drug approvals 9 first in class
- New active substance approvals 6 new active substance
- Innovative drug approvals 5 innovative
- Pediatric medicine approvals 3 pediatric
- Rare disease medicine approvals 3 rare disease
- Approved innovative drugs designated as breakthrough therapies 2 breakthrough therapy
- Common new active substance approvals across major regulatory authorities (multi-year total) 2 cumulative · common across authorities · new active substance
- Domestic first-in-class drug approvals 2 domestic · first in class
- Domestic innovative biological product approvals 2 domestic · innovative biologic
- Domestic innovative chemical drug approvals 2 domestic · innovative chemical
- Domestic innovative drug approvals (half year) 2 domestic · innovative
- Domestic share of approved innovative biological products 2 domestic · innovative biologic
Frequently asked questions
What is the latest novel drug approvals?
United States: 46 in 2025, −8.0% on 2024.
Where does this data come from?
From 3 documents published by FDA. Every figure on this page links to its record, which preserves the original source evidence.
How often is it updated?
Annual. The newest published period is 2025; the next release should cover 2026. A new figure appears here once the publisher releases it and it passes verification.
Can I use this data?
Yes. StatOrigin publishes it under CC BY 4.0: you may copy, chart and republish it, including commercially, with attribution to StatOrigin and to the original publisher.
Cite this page
Cite the page as a data set, or open any record to cite one figure: each record carries APA, MLA, Chicago and BibTeX forms that credit the original publisher.
StatOrigin. (2026). Novel drug approvals [Data set]. Retrieved October 28, 2026, from https://statorigin.org/indicators/novel-drug-approvals
"Novel drug approvals." StatOrigin, 2026, https://statorigin.org/indicators/novel-drug-approvals. Accessed 28 Oct. 2026.
StatOrigin. "Novel drug approvals." Data set, 2026. Accessed October 28, 2026. https://statorigin.org/indicators/novel-drug-approvals.
@misc{statorigin_novel_drug_approvals_2026, title = {Novel drug approvals}, author = {{StatOrigin}}, year = {2026}, url = {https://statorigin.org/indicators/novel-drug-approvals}, note = {Data set. Accessed 2026-10-28} }