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More than three years after Gilead Sciences’ hepatitis D drug bulevirtide was rebuffed by the FDA on manufacturing and delivery concerns, the treatment has redeemed itself by scoring a green light | More than three years after Gilead Sciences’ hepatitis D drug bulevirtide was rebuffed by the FDA on manufacturing and delivery concerns, the treatment has redeemed itself by scoring a green light in the U.S.
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FDA clears Gilead's hepatitis D drug, four years after prior rejection

FDA approves Hepcludex for chronic hepatitis D

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

FDA OKs First Treatment for Chronic Hepatitis D Infection

GSK's functional cure data for hepatitis B drug are a major leap over standard of care