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US Food and Drug Administration

US federal agency responsible for regulating food, drugs and medical products

Health & Medicine · FDA approves first functional cure for chronic hepatitis B, offering hope to millions

The US Food and Drug Administration has approved Hibsago (bepirovirsen), the first treatment that offers a functional cure for chronic hepatitis B, a disease affecting more than 250 million people worldwide and causing upwards of a million deaths each year. Clinical trials showed that 19% of patients achieved undetectable virus levels 24 weeks after stopping all therapy, compared with less than 1% under standard care.