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Press kit · open data
2026 FDA Approvals Tracker
Every PDUFA action, supplemental approval, and NME filing expected at the FDA in 2026. Open CSV, nightly refresh, primary sources.
Download dataset (CSV) ↓ View interactive tracker →Three headline findings
Finding 1
0 approval events tracked for 2026
Pulled from FDA AdCom transcripts, sponsor 10-Q/10-K filings, ClinicalTrials.gov NDA/BLA records, and EMA EPARs where US + EU tracked together. Includes both NMEs and supplemental sNDA/sBLA filings.
Finding 2
0% are oncology drugs
0 of the expected approvals are in oncology — the highest concentration of any therapeutic area. Reflects the post-Keytruda boom in ADCs, bispecifics, and tumour-agnostic indications.
Finding 3
0% are biologics, cell, or gene therapy
0 of the expected approvals are non-small-molecule — monoclonal antibodies, ADCs, mRNA, cell therapies, gene therapies. The small-molecule share continues to fall year-over-year.
Cite this dataset
Drug Landscape (2026). 2026 FDA Approval Calendar [Data set]. druglandscape.com. https://druglandscape.com/data/fda-approvals-2026.csv
Re-distribution allowed with attribution to druglandscape.com under our editorial policy.
Methodology
Every row in the dataset is sourced from at least one of:
- FDA Drug Approvals Database (Drugs@FDA)
- Sponsor 10-Q / 10-K filings (SEC EDGAR)
- ClinicalTrials.gov NDA/BLA-filing-stage records
- EMA European Public Assessment Reports (EPARs)
- FDA Advisory Committee transcripts
Refresh: nightly. Quality gate: four-point verification — see /editorial-policy for the full pipeline.
Press contact
Drug Landscape press desk
hello@druglandscape.com · about the team
Happy to pull specific cuts of the data (by therapeutic area, sponsor, modality, PDUFA quarter) on request. Usually 24h turnaround.