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FDA Delays Action On MedImmune's Rezield Despite Negative Panel Vote

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency may have needed more time to investigate allegations in a wrongful discharge lawsuit challenging data integrity in a motavizumab surveillance study.

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AstraZeneca's Rezield Hits Another Regulatory Wall

FDA's request for another clinical trial before approving MedImmune's Rezield for prevention of respiratory syncytial virus could reflect an advisory committee's recommendations that the company show some advantage over its currently approved RSV agent, Synagis, particularly in sicker children

AstraZeneca's Rezield Hits Another Regulatory Wall

FDA's request for another clinical trial before approving MedImmune's Rezield for prevention of respiratory syncytial virus could reflect an advisory committee's recommendations that the company show some advantage over its currently approved RSV agent, Synagis, particularly in sicker children

AstraZeneca's Rezield Hits Another Regulatory Wall

FDA issues a second "complete response" letter for the respiratory syncytial virus prophylaxis agent, this time seeking a new clinical trial.

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