FDAsafety guidance72% confidence
January - March 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 (ild) as Amgen.
Regulatory Analysis
January - March 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
Supporting Context
- Therapeutic area
- Respiratory · Asthma
- Sub-indication
- Ild
Related signal: Amgen's AMG 691 Phase 1 Study Targets Safety in Asthma Patients