C21 · Pharmaceuticals · United States
Novel drug approvals using expedited programs
United States: 33 in 2024.
- 33 Latest · United States · 2024
- Annual Release cadence
- 1 Record · 1 region · 2024
Verified 17 Sep 2026 · 1 publisher · Next period 2025
The figure
One published observation so far. A chart follows as soon as a second period is published.
Novel drug approvals using expedited programs
United States, 2024
Every record
1 record · 1 region · 2024. Each period links to its record: the value, its source evidence and original document.
Download this data
Every file carries its provenance: the CSV has a source column per row, and the chart images print the publisher, the licence and this page's address under the drawing. Source: FDA. Licence: CC BY 4.0.
Use and publication rights
- View, cite and link: free
Quote any number, cite this page or a single record, and link to it anywhere.
- Copy, chart and republish: free with attribution
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
- Number of novel therapies approved through one or more expedited regulatory review pathways.
- Measure
- One slice of Drug approvals ( counting rule: expedited program, 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 · 1 document
| Document | Publisher | Published | Data points |
|---|---|---|---|
| CDER Brings Many Safe and Effective Therapies to Patients and Consumers in 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
- Novel drug approvals 3 novel
- 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
Frequently asked questions
What is the latest novel drug approvals using expedited programs?
United States: 33 in 2024.
Where does this data come from?
From 1 document 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 2024; the next release should cover 2025. 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 using expedited programs [Data set]. Retrieved October 28, 2026, from https://statorigin.org/indicators/novel-drug-approvals-using-expedited-programs
"Novel drug approvals using expedited programs." StatOrigin, 2026, https://statorigin.org/indicators/novel-drug-approvals-using-expedited-programs. Accessed 28 Oct. 2026.
StatOrigin. "Novel drug approvals using expedited programs." Data set, 2026. Accessed October 28, 2026. https://statorigin.org/indicators/novel-drug-approvals-using-expedited-programs.
@misc{statorigin_novel_drug_approvals_using_expedited_programs_2026, title = {Novel drug approvals using expedited programs}, author = {{StatOrigin}}, year = {2026}, url = {https://statorigin.org/indicators/novel-drug-approvals-using-expedited-programs}, note = {Data set. Accessed 2026-10-28} }