Gilead's Drug Wins First-Ever US Approval for Deadly Liver Infection

FDA approves first-ever drug for hepatitis D, severe liver virus

FDA approves Gilead’s Hepcludex as first treatment for hepatitis D, a severe liver virus linked to rapid cirrhosis and cancer, marking the first antiviral option for the disease in decades

FDA Grants Accelerated Approval to Gilead’s Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV)

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 22, 2026-

FDA approves Hepcludex for chronic hepatitis D

The FDA approved Hepcludex injection for the treatment of chronic hepatitis D infection in adults without cirrhosis or with compensated cirrhosis, according to a press release. Hepcludex (bulevirtide-gmod, Gilead Sciences) is the first FDA-approved treatment for the condition.

Gilead's drug wins first-ever US approval for deadly liver infection

FDA clears Gilead's hepatitis D drug, four years after prior rejection

Gilead has at long last won US approval of its hepatitis D treatment Hepcludex, which the FDA previously rejected over issues with its manufacturing and distribution. The drug, known generically as bulevirtide, treats chronic hepatitis ...