Key facts: Enhertu Cleared for Two Breast Uses; Safety Flag on AZ RSV

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2026.05.16 07:14
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FDA cleared Enhertu for two more Stage 2–3 breast cancer uses. AstraZeneca co-develops/commercializes the drug and owes Daiichi Sankyo a $155M milestone; U.S. sales credited to Daiichi Sankyo.1FDA official Tracey Hoeg flagged safety questions about AstraZeneca PLC's infant RSV preventive during agency review of RSV treatments, prompting renewed regulatory scrutiny relevant to AZN traders.2