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Friday, May 22, 2026

Gilead accelerated approval for Hepcludex, first, only U.S. adult treatment for chronic hepatitis d

 

Gilead wins FDA accelerated approval for Hepcludex (bulevirtide-gmod) 8.5 mg as first and only U.S. adult treatment for chronic hepatitis delta virus (HDV)

  • EMA’s CHMP backs EU authorization of Gilead’s Trodelvy as first-line monotherapy for certain advanced triple‑negative breast cancer.
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