FDA has cleared Gilead’s hepatitis D drug Hepcludex (bulevirtide) after the agency previously rejected the therapy over manufacturing and distribution concerns. The approval comes roughly four years after the earlier FDA decision, putting a long-sought option back on the market for chronic hepatitis D, a disease with limited treatment pathways. The clearance resolves the manufacturing- and supply-related issues that delayed review, according to the report. Gilead’s bulevirtide works by targeting the viral entry process, aiming to reduce hepatitis D activity in patients who have limited alternatives. Industry attention is likely to focus on how Gilead implements the prior FDA feedback in ongoing operations and how payers interpret the renewed availability for a hard-to-treat population.