FDAsafety guidance83% confidence
FDA AP — SARCLISA (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Sanofi.
Regulatory Analysis
Application BLA761113. Sponsor: SANOFI AVENTIS US. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ISATUXIMAB-IRFC.
Supporting Context
- Therapeutic area
- Endocrinology · Type 1 Diabetes
- Sub-indication
- General
Related signal: Trial to Assess Recruitment Methods for Type 1 Diabetes Screening