Would AstraZeneca Be Better Off If Rezield Had Gotten A Harsher FDA Letter?
Executive Summary
AstraZeneca subsidiary MedImmune received a "complete response" letter from FDA for its RSV drug motavizumab that did not request additional clinical data, but after an unfavorable advisory committee a year and a half later, the company is looking at the prospect of having to do another trial anyway
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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.