FDAsafety guidance72% confidence
FDA AP — TECVAYLI (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Janssen.
Regulatory Analysis
Application BLA761291. Sponsor: JANSSEN BIOTECH. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: TECLISTAMAB-CQYV.
Supporting Context
- Therapeutic area
- Hematology · Multiple Myeloma
- Sub-indication
- General
Related signal: Teclistamab Combination Study in Multiple Myeloma Initiated by Janssen