FDAsafety guidance83% confidence
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Mirum Pharmaceuticals.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Hepatology · Alagille Syndrome / Progressive Familial Intrahepatic Cholestasis
- Sub-indication
- General
Related signal: Mirum Pharmaceuticals Evaluates Livmarli in Long-Term Study for Alagille Syndrome and PFIC