FDAsafety guidance83% confidence
FDA AP — IMFINZI (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to AstraZeneca.
Regulatory Analysis
Application BLA761069. Sponsor: ASTRAZENECA UK LTD. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: DURVALUMAB.
Supporting Context
- Therapeutic area
- Oncology · Head and Neck Cancer
- Sub-indication
- General
Related signal: Durvalumab and Cetuximab Combination Trial for Head and Neck Cancer