FDAsafety guidance83% confidence
FDA AP — IMMGOLIS (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to KSHB Biopharma.
Regulatory Analysis
Application BLA761452. Sponsor: ACCORD BIOPHARMA INC.. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: GOLIMUMAB-SLDI.
Supporting Context
- Therapeutic area
- Rheumatology · Biologic
- Sub-indication
- General
Related signal: KSHB002 Trial Shows Equivalence to ORENCIA in PK, Safety, and Immunogenicity for RA