FDA · United States
nivolumab — FDA regulatory status
nivolumab (OPDIVO) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- OPDIVO
- Originator
- Bristol-Myers Squibb Australia Pty Ltd
- Mechanism
- Programmed cell death protein 1 inhibitor
- Target
- Programmed cell death protein 1
- Structured fields
- 8
Sponsor / originator context: Bristol-Myers Squibb Australia Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Programmed cell death protein 1 inhibitor. Target: Programmed cell death protein 1. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 127 published clinical programs and 2 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 1479-0032 | Phase 3 | Boehringer Ingelheim | 2025-521284-12-00 |
| 20210098 | Phase 3 | Amgen | 2023-505458-16-00 |
| 2023/3764 | Phase 3 | George Institute for | 2023-503317-29-00 |
| AV-951-20-304 | Phase 3 | Anaxis Pharma | 2024-514570-43-00 |
| CA017-078 | Phase 3 | Bristol-Myers Squibb Australia | 2024-512158-12-00 |
| CA209-577 | Phase 3 | Bristol-Myers Squibb Australia | 2023-509360-24-00 |
| CA209-67T | Phase 3 | Bristol-Myers Squibb Australia | 2023-503280-42-00 |
| CA209-8HW | Phase 3 | Bristol-Myers Squibb Australia | 2023-503956-29-00 |
| CA209-8Y8 | Phase 3 | Bristol-Myers Squibb Australia | 2023-508264-29-00 |
| CA209-9DW | Phase 3 | Bristol-Myers Squibb Australia | 2023-508635-31-00 |
| CA209-9DX | Phase 3 | Bristol-Myers Squibb Australia | 2023-508726-10-00 |
| CA209-9ER | Phase 3 | Bristol-Myers Squibb Australia | 2023-509711-83-00 |
Related patents
Related hubs
FAQ
What is the FDA approval status of nivolumab?
nivolumab currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get nivolumab regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to nivolumab?
This spoke lists 127 published programs associated with nivolumab in our pipeline index.