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FDA accelerated approval of Hepcludex to address serious unmet need in US HDV market, says GlobalData

Summary by GlobalData
The US Food and Drug Administration (FDA) has recently granted accelerated approval to Gilead Sciences’ antiviral, Hepcludex (bulevirtide-gmod), for the treatment of adults with chronic hepatitis delta virus (HDV) infection without cirrhosis or with compensated cirrhosis. Hepcludex is now the first and only approved treatment for HDV patients in the US, marking a significant milestone for HDV patients and addressing a serious unmet need in the H…
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GlobalData broke the news on Wednesday, May 27, 2026.
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