Hepatology

The FDA accepted EIT Pharma’s lonafarnib NDA for chronic hepatitis D, supported primarily by the phase 3 D-LIVR trial.

FDA grants volixibat Breakthrough Therapy and Orphan Drug status for PSC pruritus, but recommends an additional phase 3 trial before NDA.

Hepatology in July 2026: Odevixibat misses phase 3 primary endpoint, zabopegdutide shows early MASH benefit, plus a new Wilson disease NDA

Topline data from the largest disease-modification trial in biliary atresia show no benefit over placebo for the primary endpoint, though the established safety profile in approved indications was maintained.

World Hepatitis Day survey findings reveal gaps in chronic hepatitis B awareness and liver cancer risk perception, with Cary James discussing elimination efforts.

Monopar initiated a rolling NDA submission for ALXN1840, an investigational therapy for Wilson disease targeting copper dysregulation.

Phase 2 data suggest zabopegdutide improved liver fat, stiffness, and fibrosis biomarkers within 12 weeks in adults with MASH.

Elafibranor achieved 85% ALP normalization at week 52 in the phase 3b ELSPIRE trial for primary biliary cholangitis.

Raj Vuppalanchi, MD, shares insights on saroglitazar, EPICS-III, and the future of personalized treatment for PBC.

First-half 2026 hepatology highlights include FDA approvals, hepatitis B and D advances, MASH progress, and AATD gene editing.

Catch up on Q2 hepatology headlines, including the historic FDA approval of bulevirtide for hepatitis delta, new data on bepirovirsen for HBV, and more.

Catch up on the latest in hepatology, from bulevirtide’s FDA approval for hepatitis delta to expert perspectives on new and emerging therapies in PBC, PSC, and MASLD.

A review of 22 novel drugs approved by the US Food and Drug Administration during the first half of 2026, with links to coverage from MJH Life Sciences publications.

An EPICS-III study investigator discusses the mechanism of action of saroglitazar to treat patients with PBC.

From hepatitis D's first FDA-approved therapy to advances in hepatitis B and PBC, May delivered major developments in hepatology.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and phase 3 data.

Pooled B-Well phase 3 data show bepirovirsen achieved a 19% functional cure rate in CHB vs 0% with standard of care alone.

Saroglitazar received FDA Priority Review for adults with PBC after phase 3 data showed improved biochemical response versus placebo.

The Liver Disease Panel represents the first comprehensive library of certified healthcare algorithms to support chronic liver disease management.

Until this decision, clinicians relied on off-label, interferon-based regimens with limited efficacy.

GI and liver safety signals for clinicians to know from the VISTAS evaluating volixibat in PSC-associated pruritus.

Kowdley explains phase 2b VISTAS data suggesting volixibat rapidly reduced PSC-associated pruritus in adults with limited treatment options.

Lee discusess DDW 2026 data linking binge drinking frequency to advanced hepatic fibrosis in SLD.

Noureddin discusses HU6’s mitochondrial uncoupling mechanism and why muscle preservation may become increasingly important in MASH care.

Catch up on updates in viral hepatitis treatment, advances in rare liver disease care, and more.