FDAsafety guidance72% confidence
FDA AP — PROLIA (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Amgen.
Regulatory Analysis
Application BLA125320. Sponsor: AMGEN. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: DENOSUMAB.
Supporting Context
- Therapeutic area
- Endocrinology · Obesity and Type 2 Diabetes
- Sub-indication
- General
Related signal: Amgen's MARITIME-2-EXTENSION Trial Evaluates Maridebart Cafraglutide for Obesity and Type 2 Diabetes