FDAsafety guidance83% confidence
FDA AP — ZYNYZ (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Incyte.
Regulatory Analysis
Application BLA761334. Sponsor: INCYTE CORP. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: RETIFANLIMAB-DLWR.
Supporting Context
- Therapeutic area
- Oncology · Anal Cancer
- Sub-indication
- General
Related signal: Study on ctHPVDNA Response-Adapted Chemoradiation with Retifanlimab in Anal Cancer