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Data

New drugs approved in the United States

See all data and research on:
Medicine & Biotechnology

What you should know about this indicator

This data includes both (NDAs) and (BLAs) approved by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the FDA.

New drugs approved in the United States
The annual number of new drugs approved by the US Food and Drug Administration (FDA). This is broken down into , new vaccines, and other new biologics such as antibodies and gene therapies. The data does not include , reformulations, or .
Source
US Food and Drug Administration (2025) – with major processing by Our World in Data
Last updated
July 16, 2025
Next expected update
July 2026
Date range
1924–2025
Unit
approvals

What you should know about this indicator

This data includes both (NDAs) and (BLAs) approved by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the FDA.

New drugs approved in the United States
The annual number of new drugs approved by the US Food and Drug Administration (FDA). This is broken down into , new vaccines, and other new biologics such as antibodies and gene therapies. The data does not include , reformulations, or .
Source
US Food and Drug Administration (2025) – with major processing by Our World in Data
Last updated
July 16, 2025
Next expected update
July 2026
Date range
1924–2025
Unit
approvals

Sources and processing

This data is based on the following sources

US Food and Drug Administration – CDER New Molecular Entity (NME) Drug and New Biologic Approvals

This dataset provides a listing of all new drugs approved from 1985 – 2024 and regulated by the Center for Drug Evaluation and Research (CDER). The listed drugs include both small molecule drugs approved under a New Drug Application (NDA) and new biological products approved under a Biologics License Application (BLA). The product information, indications, and regulatory characteristics described in the compilation reflect the state of each application at the time of original marketing approval.

This dataset is a subset of all drugs approved by the FDA, as it does not include any biologics approved by the Center for Biologics Evaluation and Research (CBER) such as vaccines, allergenic products, or blood and blood components. It also does not include generic drugs or reformulations of existing drugs.

Retrieved on
July 16, 2025
Retrieved from
https://www.fda.gov/drugs/drug-approvals-and-databases/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals
Citation
This is the citation of the original data obtained from the source, prior to any processing or adaptation by Our World in Data. To cite data downloaded from this page, please use the suggested citation given in Reuse This Work below.
Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals, United States Food and Drug Administration, https://www.fda.gov/drugs/drug-approvals-and-databases/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals, (2025)

This dataset provides a listing of all new drugs approved from 1985 – 2024 and regulated by the Center for Drug Evaluation and Research (CDER). The listed drugs include both small molecule drugs approved under a New Drug Application (NDA) and new biological products approved under a Biologics License Application (BLA). The product information, indications, and regulatory characteristics described in the compilation reflect the state of each application at the time of original marketing approval.

This dataset is a subset of all drugs approved by the FDA, as it does not include any biologics approved by the Center for Biologics Evaluation and Research (CBER) such as vaccines, allergenic products, or blood and blood components. It also does not include generic drugs or reformulations of existing drugs.

Retrieved on
July 16, 2025
Retrieved from
https://www.fda.gov/drugs/drug-approvals-and-databases/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals
Citation
This is the citation of the original data obtained from the source, prior to any processing or adaptation by Our World in Data. To cite data downloaded from this page, please use the suggested citation given in Reuse This Work below.
Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals, United States Food and Drug Administration, https://www.fda.gov/drugs/drug-approvals-and-databases/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals, (2025)

How we process data at Our World in Data

All data and visualizations on Our World in Data rely on data sourced from one or several original data providers. Preparing this original data involves several processing steps. Depending on the data, this can include standardizing country names and world region definitions, converting units, calculating derived indicators such as per capita measures, as well as adding or adapting metadata such as the name or the description given to an indicator.

At the link below you can find a detailed description of the structure of our data pipeline, including links to all the code used to prepare data across Our World in Data.

Read about our data pipeline
Notes on our processing step for this indicator
  • Biologicals approved by the CBER have been extracted from the FDA's "Purple Book", which lists all licensed biological products.
  • CDER approvals (which include some biologics and all chemical drugs) come directly from the "Compilation of CDER NME and New Biologic Approvals" database, which is published by CDER.
  • This dataset only contains new drugs ( and biologics). We removed and from the dataset, by excluding the "biosimilar" or "interchangeable" license types as well as products with a reference product listed.

Reuse this work

  • All data produced by third-party providers and made available by Our World in Data are subject to the license terms from the original providers. Our work would not be possible without the data providers we rely on, so we ask you to always cite them appropriately (see below). This is crucial to allow data providers to continue doing their work, enhancing, maintaining and updating valuable data.
  • All data, visualizations, and code produced by Our World in Data are completely open access under the Creative Commons BY license. You have the permission to use, distribute, and reproduce these in any medium, provided the source and authors are credited.

Citations

How to cite this page

To cite this page overall, including any descriptions, FAQs or explanations of the data authored by Our World in Data, please use the following citation:

“Data Page: New drugs approved in the United States”. Our World in Data (2025). Data adapted from US Food and Drug Administration. Retrieved from https://archive.ourworldindata.org/20250918-120114/grapher/new-drugs-approved-in-the-united-states.html [online resource] (archived on September 18, 2025).

How to cite this data

In-line citationIf you have limited space (e.g. in data visualizations), you can use this abbreviated in-line citation:

US Food and Drug Administration (2025) – with major processing by Our World in Data

Full citation

US Food and Drug Administration (2025) – with major processing by Our World in Data. “New drugs approved in the United States” [dataset]. US Food and Drug Administration, “CDER New Molecular Entity (NME) Drug and New Biologic Approvals” [original data]. Retrieved December 5, 2025 from https://archive.ourworldindata.org/20250918-120114/grapher/new-drugs-approved-in-the-united-states.html (archived on September 18, 2025).