May 22, 2026
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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.
May 22, 2026
1 min read
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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)

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

FDA OKs First Treatment for Chronic Hepatitis D Infection

After prior FDA manufacturing snub, Gilead's hepatitis D med Hepcludex nabs US nod

AbbVie Announces Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C Infection

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

Gilead has at long last won US approval of its hepatitis D treatment Hepcludex, which the FDA previously rejected over issues…

In phase III study, patients taking bulevirtide had ALT normalization and steep drops in HDV RNA

More than three years after Gilead Sciences’ hepatitis D drug bulevirtide was rebuffed by the FDA on manufacturing and delivery…

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The FDA has granted premarket approval to HepQuant’s liver diagnostic test for the treatment of adults with Child-Pugh Class A…