The FDA approved Gilead’s hepatitis D therapy Hepcludex (bulevirtide) roughly four years after the agency rejected the drug earlier, citing manufacturing and distribution concerns. The approval clears a major regulatory overhang for a treatment class that had been awaiting resolution of CMC gaps. The earlier FDA refusal and the intervening rework increase the importance of quality systems and supply-chain readiness for next-cycle launches in infectious disease—especially where production complexity can delay access. With this authorization, Gilead re-enters the hepatitis D treatment market with a newly cleared pathway, which may also shift how clinicians sequence therapy for chronic hepatitis D.