How often is this dataset updated?

Updated monthly from primary sources: Drugs@FDA.

How do I cite this dataset?

Drug Landscape (2026). 2025 FDA Drug Approvals. druglandscape.com/datasets/fda-approvals-2025. Accessed [date].

2025 FDA Drug Approvals

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

All FDA approval actions in calendar year 2025.

~600 rows ~140 KB CSV Updated monthly United States 2025 Free

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About this dataset

Historical dataset of 2025 FDA approvals — NMEs, sNDAs, sBLAs, and biosimilars. Final retrospective version published Q1 2026 after all 2025 PDUFA windows closed.

Schema

Column	Description	Type
`drug_id`	Drug Landscape stable identifier	string
`brand_name`	Trade name	string
`generic_name`	Generic name	string
`company_name`	Sponsor	string
`approval_date`	Approval date (ISO 8601)	date
`therapeutic_area`	Therapeutic area	string

Sources

Drugs@FDA.

Citation

APA

Drug Landscape. (2026). 2025 FDA Drug Approvals (Version 2026.05) [Data set]. Drug Landscape. https://druglandscape.com/datasets/fda-approvals-2025

BibTeX

@dataset{DrugLandscape2025FDAApprovals,
  author       = {Drug Landscape},
  title        = {2025 FDA Drug Approvals},
  year         = {2026},
  version      = {2026.05},
  publisher    = {Drug Landscape},
  url          = {https://druglandscape.com/datasets/fda-approvals-2025},
  note         = {~600 rows; source: Drugs@FDA}
}

RIS

TY  - DATA
T1  - 2025 FDA Drug Approvals
AU  - Drug Landscape
PY  - 2026
ET  - 2026.05
PB  - Drug Landscape
UR  - https://druglandscape.com/datasets/fda-approvals-2025
ER  -

License

Free for any use including commercial, with attribution to Drug Landscape (druglandscape.com). Full terms in our editorial policy.