FDAsafety guidance72% confidence
FDA AP — DARZALEX (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Janssen.
Regulatory Analysis
Application BLA761036. Sponsor: JANSSEN BIOTECH. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: DARATUMUMAB.
Supporting Context
- Therapeutic area
- Nephrology · Light Chain Cast Nephropathy
- Sub-indication
- General
Related signal: Study on Plasma Exchange vs. Daratumumab for Light Chain Cast Nephropathy