The US Food and Drug Administration's cancer leadership appeared visibly frustrated 25 July that AstraZeneca PLC submitted a perioperative drug application that did not follow the agency’s six-year-old advice to characterize the contribution of each phase of therapy.
BMS’s Opdivo May Be Next Casualty Of US FDA’s Perioperative Trial Redesign Push
AstraZeneca’s Imfinzi lung cancer advisory panel, which offered insight into why sponsors do not always follow agency advice, likely is a preview of the hurdle facing Bristol Myers Squibb’s Opdivo application for the same indication.
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