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Regulatory Updates | Pharmacountry Insights

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Regulatory Updates

FDA, EMA, TGA and global regulatory developments

#Durvalumab ×

Daily News Market Analysis Research & Reports Regulatory Updates

Regulatory Updates

Sep 18, 2026•3 min read

FDA Grants Priority Approval for AstraZeneca's IMFINZI (Durvalumab) BLA761069

The FDA approved AstraZeneca’s IMFINZI (durvalumab) under BLA761069, with priority review for efficacy and ongoing labeling updates through 2026.