FDAsafety guidance72% 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
- Neurology · Alzheimer's Disease
- Sub-indication
- General
Related signal: Bristol-Myers Squibb initiates Phase 3 trial for KarXT + KarX-EC in Alzheimer's agitation