FDA approves Gilead's Hepcludex as first HDV treatment in U.S.
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FDA Grants Accelerated Approval to Gilead’s Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV)
May 22, 2026 2:00 PM EDTChronic HDV is considered the most severe form of viral hepatitis due to rapid disease progression towards liver failure and liver-related death
Approval introduces the first FDA-approved therapy for this disease with limited treatment options and high unmet need
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis... More
