The FDA Has Accepted Under Priority Review AstraZeneca's Supplemental Biologics License Application For Imfinzi (Durvalumab) For Limited-Stage Small Cell Lung Cancer Whose Disease Has Not Progressed Following Platinum-based Concurrent Chemoradiotherapy, With Prescription Drug User Fee Act Date Anticipated During Fourth Quarter Of 2024
Portfolio Pulse from Benzinga Newsdesk
The FDA has accepted AstraZeneca's supplemental biologics license application for Imfinzi (Durvalumab) under priority review for limited-stage small cell lung cancer. The Prescription Drug User Fee Act date is anticipated during the fourth quarter of 2024.

August 15, 2024 | 8:55 am
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
The FDA has accepted AstraZeneca's supplemental biologics license application for Imfinzi under priority review for limited-stage small cell lung cancer. The Prescription Drug User Fee Act date is anticipated during the fourth quarter of 2024.
The acceptance of the application under priority review indicates a potentially faster approval process, which is positive news for AstraZeneca. This could lead to increased market confidence and a potential rise in stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100