FDA · United States
cemiplimab-rwlc — FDA regulatory status
cemiplimab-rwlc (LIBTAYO) 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
- LIBTAYO
- Originator
- Regeneron UK Limited
- Mechanism
- Programmed cell death protein 1 inhibitor
- Target
- Programmed cell death protein 1
- Structured fields
- 8
Sponsor / originator context: Regeneron UK Limited. 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: 41 published clinical programs and 12 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 |
|---|---|---|---|
| Cemiplimab | Phase 3 | Regeneron UK | NCT06585410 |
| Cemiplimab | Phase 3 | Regeneron UK | NCT06616584 |
| Cemiplimab | Phase 3 | Regeneron UK | NCT03889912, NCT03969004 |
| Cemiplimab | Phase 3 | Regeneron UK | NCT03257267 |
| cemiplimab | Phase 3 | Regeneron UK | NCT03916627, NCT06465329 |
| Cemiplimab | Phase 2 | Regeneron UK | NCT04706715 |
| Cemiplimab | Phase 2 | Regeneron UK | NCT06623656 |
| Cemiplimab | Phase 2 | Regeneron UK | NCT07058012 |
| Cemiplimab | Phase 2 | Regeneron UK | NCT04646005 |
| Cemiplimab | Phase 2 | Regeneron UK | NCT07414992 |
| Cemiplimab | Phase 2 | Regeneron UK | NCT06981325 |
| Cemiplimab | Phase 2 | Regeneron UK | NCT07433673 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12419963 | Diels-Alder conjugation methods | US |
| 12421512 | CRISPR/Cas screening platform to identify genetic modifiers of tau seeding or aggregation | US |
| 12396444 | Mouse comprising a humanized TRKB locus | US |
| 12396952 | Tuning of release kinetics in hydrogels | US |
| 12391734 | PD-1 homing endonuclease variants, compositions, and methods of use | US |
| 12391920 | Models of tauopathy | US |
| 12377159 | Steroids and protein-conjugates thereof | US |
| 12370257 | Materials and methods of treating MHC-I-opathy risk haplotypes | US |
| 12365711 | TGFβ signal convertor | US |
| 12350374 | Fabrication of protein-encapsulating microgels | US |
| 12338199 | Bis-octahydrophenanthrene carboxamides and protein conjugates thereof | US |
| 12325752 | Immunoglobulin proteins that bind to NPR1 agonists | US |
Related hubs
FAQ
What is the FDA approval status of cemiplimab-rwlc?
cemiplimab-rwlc 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 cemiplimab-rwlc 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 cemiplimab-rwlc?
This spoke lists 41 published programs associated with cemiplimab-rwlc in our pipeline index.