FDA Office of Orphan Products Development
Quick facts
Phase 3 pipeline
- chondrocyte-alginate gel suspension · Orthopedics
Chondrocyte-alginate gel suspension is a cell-based therapy that delivers chondrocytes to repair damaged cartilage. - monoclonal antibody cA2 · Oncology
cA2 targets the CD19 protein on B cells to induce their destruction.
Phase 2 pipeline
Phase 1 pipeline
Competitive intelligence
For the full portfolio CI brief — phase mix, recent regulatory actions, upcoming PDUFA dates, patent timeline, class-overlap with competitors:
- FDA Office of Orphan Products Development portfolio CI brief
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Frequently asked questions about FDA Office of Orphan Products Development
What is FDA Office of Orphan Products Development's pipeline?
FDA Office of Orphan Products Development has 2 drugs in Phase 3, 1 in Phase 2, 2 in Phase 1. Late-stage candidates include chondrocyte-alginate gel suspension, monoclonal antibody cA2.
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