Abigail Brooks, MA

The 2025 cholangitis year in review covers PBC and PSC advances, FDA designations, trial data, and evolving treatment pathways.

The gastroenterology year in review covers FDA approvals, IBD breakthroughs, IL-23 therapies, new guidelines, and advances in GI care.

The hepatology year in review highlights FDA approvals, MASH therapies, viral hepatitis advances, cholestatic disease shifts, and evolving clinical guidance.

The approval indicates narsoplimab as the first and only treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy.

The hepatitis year in review covers FDA approvals, HBV and HDV breakthroughs, HCV label expansion, clinical guidelines, and vaccine policy changes.

The MASH/MASLD year in review highlights FDA approvals, resmetirom data, semaglutide, pemvidutide, and advances in fibrosis and noninvasive endpoints in 2025.

The approval is based on the 64-week phase 3 OASIS 4 trial showing an average weight loss of ~17% if all patients stayed on treatment with semaglutide and ~14% regardless of if patients stayed on treatment.

The approval is based on phase 3 SEQUOIA-HCM clinical trial. The full US Prescribing Information includes a Boxed Warning for the risk of heart failure.

The decision makes nerandomilast the first and only PDE4B inhibitor with immunomodulatory and antifibrotic effects approved in this indication.

Positive topline results from the phase 2b IMPACT trial show statistically significant improvements in key noninvasive tests with pemvidutide.

Grifols’ fibrinogen concentrate is now approved for acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency.

The highly selective oral TYK2 inhibitor met coprimary endpoints for sPGA 0/1 and PASI 75 at week 16 versus placebo in the phase 3 Latitude studies.

AASLD and AST have released 2 new guidelines on evaluating adult liver transplant candidates and managing non-graft complications after transplantation.

Depemokimab-ulaa is the first and only ultra-long-acting biologic with twice-yearly dosing for patients with severe asthma with an eosinophilic phenotype.

Study findings highlight the prevalence of steroid use in IBD care and identify key subgroups at higher risk of exposure.

Findings link GLP-1 RA use to reduced HCC risk in patients with type 2 diabetes, with benefits partly attributable to avoiding insulin's potential hepatotoxicity.

The Holly system is a first-of-its-kind implantable, continuous dialysis system designed to give patients freedom from the cycle of center-based dialysis.

Findings from the CARE feasibility RCT show the safety, feasibility, and likely cost-effectiveness of intentional weight loss before colorectal cancer surgery.

The approval makes inebilizumab-cdon the first and only CD19-targeted B cell therapy indicated for anti-AChR and anti-MuSK Ab+ generalized myasthenia gravis.

The approval of a dye- and preservative-free powder formulation of trofinetide offers a new option for adult and pediatric patients with Rett syndrome.

Historic progress in renal xenotransplantation in 2025 brings pig kidney transplants closer to clinical reality amid an ongoing donor organ shortage.

The approval makes etuvetidigene autotemcel (Waskyra) the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome.

The approval of Ayrmid’s omidubicel-onlv makes it the first hematopoietic stem cell transplant therapy to treat patients with severe aplastic anemia.

The 8-3 APIC vote recommends individual-based decision-making for HBV vaccination in infants born to women who test negative for the virus.

Catch up on new AASLD MASH guidelines on semaglutide, key research from The Liver Meeting 2025, and more.

The accelerated approval expands Avance use to motor, mixed, and long-gap sensory nerve injuries, with required confirmatory trials to verify clinical benefit.

Catch up on GI FDA news, new American Gastroenterological Association Crohn’s disease guidelines, and more gastroenterology updates from November.

State- and local-level disparities in the availability of gastroenterologist care disproportionately affect patients with IBD and populations living in rural and high-poverty areas.

Study findings suggest ChatGPT and Gemini both require further model improvements before relying solely on LLMs in clinical nutrition practice.

Children with MASLD were more likely to live in neighborhoods with greater socioeconomic and environmental disadvantage than those with overweight or obesity but without MASLD.