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Dec 22, 2025 12:00 PM

FDA Flags Deadly Risks, AstraZeneca Pulls Andexxa From US Market

The U.S. Food and Drug Administration (FDA) said the safety risks associated with Andexxa now outweigh its benefits, prompting AstraZeneca Plc (NASDAQ:AZN) to seek a voluntary withdrawal of the drug’s biologics license and plan an exit from the U.S. market.

In November 2024, the Cellular, Tissue, and Gene Therapies Advisory Committee discussed a supplemental biologics license application for Andexxa.

Before the meeting, the FDA panel released brief documents highlighting some safety issues and other concerns.

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