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May 18, 2026 4:00 PM

AstraZeneca Scores Key FDA Wins Across Cardiovascular And Oncology Portfolios

On Monday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc's (NASDAQ:AZN) Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor, for adults with hypertension whose blood pressure remains uncontrolled despite taking other antihypertensive medicines.

Mineralys Therapeutics Inc. (NASDAQ:MLYS) also has lorundrostat under FDA review for hypertension, with a decision date of 22 December.

AstraZeneca Secures FDA Approval For Baxfendy In Hypertension

The company also announced expanded FDA approvals for Enhertu in HER2-positive early breast cancer alongside partner Daiichi Sankyo.

Baxfendy is designed to lower blood pressure by selectively blocking aldosterone production, a hormone linked to elevated blood pressure and increased cardiovascular and kidney risks.

AstraZeneca said nearly half of U.S. patients ...