Alex Hillenbrand

SPY003 cut histologic disease activity by 10 points at 12 weeks, completing proof-of-concept for Spyre's IBD combinations.

Gastroenterology in August 2026: RAS inhibitor approval for pancreatic cancer, ABTECT UC data, CRC screening mortality, and GI cancer risk.

Hepatology in August 2026: FDA designations for volixibat and lonafarnib, ketogenic diet liver data, and alcohol use in CLD.

The phase 2a study found TEV '408 significantly reduced intestinal damage and inflammation versus placebo at week 8

A joint ESC/ERA guideline on universal CKD screening headlines August 2026's nephrology news, alongside new finerenone and sibeprenlimab trial data.

New RCT finds ketogenic diet cuts liver fat and improves glycemic control more than Mediterranean or plant-forward diets after matched weight loss.

A phase 2 study found the EAP regimen achieved optimal stem cell mobilization in most patients with multiple myeloma or lymphoma, with low plerixafor need.

Daraxonrasib (Rasonque) extended median survival to 13.2 months versus 6.7 months with chemotherapy in a phase 3 trial.

Nipocalimab-aahu (IMAAVY) is now approved for wAIHA, based on Phase 2/3 ENERGY trial data showing durable hemoglobin response.

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.

A new BEACON-HCC framework for liver cancer treatment matched expert decisions 96.6% of the time in a pilot study, outperforming BCLC 2025.

Hematology in July 2026: FDA priority review for Agios' mitapivat in sickle cell disease, plus Orca-T's approval for GVHD-free survival.

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

Sibeprenlimab (Voyxact) achieves KDIGO goal, stabilizing eGFR decline in IgA nephropathy at 2-year Phase 3 VISIONARY readout.

Gastroenterology in July 2026: FDA approves Freenome's SimpleScreen CRC blood test, plus new duvakitug data in UC and Crohn disease.

Nephrology in July 2026: FDA approvals for atacicept, iptacopan, and Furoscix in IgAN/CKD, plus new IgAN and CKD trial data.

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.

FDA approves Freenome's SimpleScreen CRC blood test for colorectal cancer screening in average-risk adults aged ≥45 years.

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.

Agios ends tebapivat development in sickle cell disease after phase 2 results show no differentiated benefit.

The FDA granted traditional approval to Novartis’ iptacopan (Fabhalta) for adults with primary IgA nephropathy, supported by phase 3 APPLAUSE-IgAN data showing slowed kidney function decline and sustained proteinuria reductions.

FDA grants priority review to obinutuzumab, positioning it as the first potential approved therapy for primary membranous nephropathy.

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

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

Catch up on some of the biggest FDA news, clinical trial updates, and featured HCPLive coverage from the first half of 2026.

Review the biggest gastroenterology news from the first half of 2026, including FDA updates, IBD advances, and key clinical trials.

The FDA granted accelerated approval to atacicept to reduce proteinuria in adults with primary IgAN at risk for disease progression

FDA grants Priority Review to Agios’ mitapivat sNDA for sickle cell disease, with a PDUFA date set for November 1, 2026.