FDAsafety guidance83% confidence
October - December 2022 | 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 (lung cancer) as AstraZeneca.
Regulatory Analysis
New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
Supporting Context
- Therapeutic area
- Oncology · Immunotherapy
- Sub-indication
- Lung Cancer
Related signal: Phase III Trial of Durvalumab Post-Surgery in Early-Stage NSCLC Shows Potential Benefit