Gilead won US approval for its hepatitis D drug Hepcludex (bulevirtide) after the FDA previously rejected the therapy roughly four years earlier. The agency cited manufacturing and distribution issues in the earlier denial, and the latest action clears the path for use in chronic hepatitis D. For developers and clinicians, the decision highlights how post-denial fixes—particularly around supply chain readiness—can be as determinative as clinical performance in approval outcomes. It also positions Hepcludex for competition in a market where unmet need remains significant and treatment options have been constrained.