FDAsafety guidance72% confidence
FDA AP — OPDIVO QVANTIG (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 BLA761381. Sponsor: BRISTOL-MYERS SQUIBB. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: NIVOLUMAB, HYALURONIDASE-NVHY.
Supporting Context
- Therapeutic area
- Oncology · Immunotherapy
- Sub-indication
- General
Related signal: Study on Treatment Patterns for Nivolumab in Community Oncology Settings