2026 FDA Drug Approvals

Every confirmed and projected FDA approval action in calendar year 2026 — new molecular entities, supplemental approvals, biosimilars.

~500 rows ~120 KB CSV Updated daily United States 2026 Free

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About this dataset

Comprehensive 2026 FDA approvals dataset covering new molecular entities (NMEs), supplemental new drug applications (sNDAs), supplemental biologics license applications (sBLAs), and biosimilar approvals. Sourced from Drugs@FDA daily, cross-referenced with FDA Advisory Committee briefing documents and sponsor 8-K filings.

Schema

ColumnDescriptionType
drug_idDrug Landscape stable identifier (URL slug)string
brand_nameTrade name / brand namestring
generic_nameNon-proprietary (generic) namestring
company_nameMarketing applicant / sponsorstring
approval_dateFDA approval action date (ISO 8601)date
application_numberFDA application number (NDA or BLA)string
therapeutic_areaPrimary therapeutic areastring
drug_classPharmacologic classstring
mechanismMechanism of action (one-sentence)string

Sources

Drugs@FDA, FDA Orange Book, FDA Advisory Committee briefing documents, sponsor 8-K filings.

Citation

APA

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

BibTeX

@dataset{DrugLandscape2026FDAApprovals,
  author       = {Drug Landscape},
  title        = {2026 FDA Drug Approvals},
  year         = {2026},
  version      = {2026.05},
  publisher    = {Drug Landscape},
  url          = {https://druglandscape.com/datasets/fda-approvals-2026},
  note         = {~500 rows; source: Drugs@FDA, FDA Orange Book, FDA Advisory Committee briefing documents, sponsor 8-K filings}
}

RIS

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

License

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

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