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

Alex Hillenbrand is an assistant editor for HCPLive. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

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.

Here are 7 of the biggest nephrology stories from Q2 of 2026!

Catch up on the nephrology headlines you missed in June 2026.

Abivax’s ABTECT Part 2 showed Week 44 responses and safety consistency with obefazimod in refractory UC patients.

FDA sends fresh CRL for Unicycive’s OLC; manufacturing inspection delays approval, while data support a lower pill-burden phosphate binder.

Tulisokibart became the first anti-TL1A therapy to achieve clinical remission in a phase 3 ulcerative colitis trial.

Baseline characteristics, including sex and comorbidities, were associated with semaglutide weight loss outcomes in >36,000 adults.

Fezolinetant's CNS safety Profile Reassures Across More Than 3,000 Women in Pooled Phase 3 Analysis at ENDO 2026

ENDO 2026 data suggest tirzepatide may improve renal transplant eligibility in patients with T2D, CKD, and severe obesity.

At ENDO 2026, findings suggest SBP reductions in adults with diabetes are driven by weight loss, not GLP-1 therapy type.

Greater BMI reduction with semaglutide in adolescents with severe obesity was tied to improved triglycerides, TG/HDL ratio, and HbA1c

New systematic review of 7012 kidney transplant recipients with T2D finds GLP-1 receptor agonists cut major adverse kidney events and mortality by 61%.

MiniMed 780G improved HbA1c and time in range in real-world diabetes data presented at ENDO 2026, with minimal hypoglycemia risk.

Learn what the first-ever CKM syndrome guideline means for screening, treatment, and the connection between heart disease, kidney disease, diabetes, and obesity.

Catch up on the key nephrology news, research findings, and expert insights featured on HCPLive throughout May 2026.

FDA accepts the BLA for povetacicept in IgA nephropathy, supported by positive phase 3 RAINIER trial data.

Catch up on 5 notable studies and trial updates from DDW 2026!

Catch up on the hematology news and data you missed from April 2026.

COBRA findings suggest 1 day of antibiotic treatment is preferred in acute cholangitis after adequate biliary drainage compared to longer guidelines.

November 24th 2025