FDAsafety guidance72% confidence
October - December 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
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
October - December 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
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