FDAsafety guidance83% confidence
FDA AP — OPDUALAG (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Bristol-Myers Squibb.
Regulatory Analysis
Application BLA761234. Sponsor: BRISTOL MYERS SQUIBB. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: NIVOLUMAB, RELATLIMAB-RMBW.
Supporting Context
- Therapeutic area
- Oncology · Immunotherapy
- Sub-indication
- General
Related signal: Study on Treatment Patterns for Nivolumab in Community Oncology Settings