FDA Flags Deadly Risks, AstraZeneca Pulls Andexxa From US Market
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AstraZeneca will cease sales of Andexxa in the US after the FDA deemed its safety risks outweigh benefits. The FDA's review showed serious thromboembolic events in patients using Andexxa. AstraZeneca plans to withdraw the biologics license and end US sales by Dec. 22, 2025. Andexxa, approved in 2018, was designed to reverse anticoagulation in patients with life-threatening bleeding. Clinical trials revealed higher thrombosis rates, prompting the withdrawal. AstraZeneca shares fell 0.28% to $91.10.
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