FDAsafety guidance72% confidence
S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (liver cancer) as Alnylam Pharmaceuticals.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Hepatocellular Carcinoma
- Sub-indication
- Liver Cancer
Related signal: Alnylam's ALN-BCAT Study in Hepatocellular Carcinoma Evaluates Safety and Efficacy