FDAsafety guidance66% confidence
FDA AP — OPDUALAG (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Bristol Myers Squibb; the same agency is already in play for this signal, so precedent weight is higher.
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 · Combination Therapy
- Sub-indication
- General
Related signal: FDA Accepts Supplemental Application for OPDUALAG by Bristol Myers Squibb