FDA has granted approval to Gilead’s hepatitis D therapy Hepcludex (bulevirtide) after the agency previously rejected the drug over manufacturing and distribution issues. The decision reopens a treatment pathway for patients with chronic hepatitis D, a serious viral infection with limited options. The approval arrives four years after FDA’s initial refusal, signaling that Gilead has addressed regulator concerns tied to product consistency and logistics. Hepcludex is positioned as the new standard for chronic hepatitis D where appropriate clinical criteria are met. For biotech and pharma stakeholders, the update is also a reminder that late-stage label timing can hinge as much on CMC and supply execution as on clinical performance.