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FDA approves first treatment for chronic hepatitis delta virus infection

The U.S. Food and Drug Administration has approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta ...

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

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated ...
Pharmabiz

US FDA grants accelerated approval to Gilead’s Hepcludex for the treatment of chronic hepatitis delta virus

US FDA grants accelerated approval to Gilead’s Hepcludex for the treatment of chronic hepatitis delta virus: Foster City, California Tuesday, May 26, 2026, 10:00 Hrs [IST] Gilea ...
Medscape

FDA Approves Bulevirtide for Hepatitis Delta Virus

The FDA approved bulevirtide (Hepcludex; Gilead Sciences), the first treatment for hepatitis delta virus (HDV) infection in the US. The 8.5-mg daily injection will treat adults with chronic HDV ...
PharmExec

FDA Approves Hepcludex as First and Only Approved Treatment for Chronic Hepatitis Delta Virus

FDA approves Gilead’s Hepcludex as the first treatment for chronic hepatitis delta virus in the U.S., marking a major ...