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FDA delays ruling on AstraZeneca’s breast cancer drug after negative adcomm vote
The FDA has delayed a decision on the approval of AstraZene | The FDA has delayed a decision on the approval of AstraZeneca’s camizestrant, deferring its ruling to review analyses filed after an advisory committee voted against the breast cancer prospect.
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biopharmadive.com
FDA delays decision on AstraZeneca breast cancer pill
The review extension comes weeks after an advisory panel found the evidence supporting the drug, camizestrant, inconclusive in what would be a new kind of treatment setting.
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independent.co.uk
AstraZeneca’s ‘game changer’ cancer pill stuck in limbo as FDA demands more data
This extension follows an April vote by a majority of the FDA's advisory panel against the drug when used in combination with a CDK4/6 inhibitor
