FDAsafety guidance72% confidence
FDA AP — TREMFYA (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Janssen.
Regulatory Analysis
Application BLA761061. Sponsor: JANSSEN BIOTECH. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: GUSELKUMAB.
Supporting Context
- Therapeutic area
- Dermatology · Psoriasis
- Sub-indication
- General
Related signal: Janssen's Guselkumab Trial Targets Skin of Color Patients with Psoriasis