Abigail Brooks, MA

The Q3 recap for hepatology spotlights key FDA news, the withdrawal of OCA for PBC, and notable hepatic research from the past few months.

The Q3 recap for nephrology spotlights key FDA decisions, new KDIGO IgA nephropathy guidelines, and other top renal news and research.

Read about new AGA gastroparesis guidelines, GI FDA news, and more.

Read about hepatic FDA news, the voluntary withdrawal of obeticholic acid for PBC, new trial data for a potential AATD drug, and more.

Check out renal FDA news, new KDIGO guidelines on IgAN and IgAV management, research about hypertensive kidney disease, and more.

Both organizations defend the use of Tylenol during pregnancy, citing “rigorous” and “reputable” research suggesting it does not cause autism in children.

Denecimig may offer a prophylaxis bleed treatment option for a range of patients across dosing frequencies, age groups, and condition severity.

The resubmission is based on results from 5 randomized clinical trials in the ONWARDS type 2 diabetes phase 3a program.

The approval of the selectively targeted somatostatin receptor type 2 agonist is supported by data from the phase 3 PATHFNDR-1 and PATHFNDR-2 trials.

The extended indication includes children 1 to < 5 years of age with homozygous familial hypercholesterolemia.

Both ACOG and AAP have released statements disagreeing with the FDA label change for acetaminophen to reflect autism risk in children if used during pregnancy.

Findings from an analysis of GBD 2021 data highlight increases in the absolute number of ASCVD cases and deaths among the working-age population.

Findings suggest post-stroke dysphagia is associated with adverse psychosocial outcomes at 3 months, emphasizing the need for comprehensive rehabilitation strategies.

The Agency initiated an acetaminophen label change to reflect evidence of potential harms in pregnant women and an approval of leucovorin for CFD.

Phase 3 STRIVE-ON Safety Trial results were presented at the 2025 Neurocritical Care Society annual meeting and suggest GTx-104’s viability over oral nimodipine.

The approval offers the flexibility of self-administration from the start of treatment for UC, building on the prior approval of SC induction in Crohn’s disease.

The guideline offers 12 conditional recommendations for the diagnosis and management of gastroparesis, emphasizing individualized care and calling for more research.

The 2025 guideline updates previous recommendations made in the 2021 glomerular disease guideline based on recent therapeutic advances in IgAN.

The label update expands the treatment eligible population to include dystrophic epidermolysis bullosa patients from birth and allows at-home application.

Intercept Pharmaceuticals has voluntarily withdrawn obeticholic acid from the US market following a request from the FDA.

Upon further review of the sNDA, the Agency indicated an advisory committee for sparsentan in FSGS is no longer needed.

For the first time, the FDA has accepted the initiation of the qualification of an NIT as a noninvasive surrogate endpoint in drug development for MASH.

The first patient in the ongoing Multi-Patient Expanded Access study has surpassed 7 months kidney function, and a second patient has been successfully transplanted.

The death rate from high blood pressure-related kidney disease increased by 48% from 1999-2023, with notable disparities by race, ethnicity, sex, and region.

Findings highlight a 33% increase in 1-year and nearly 50% increase in 5-year post-transplant survival with a living versus deceased donor transplant.

WVE-006 drove production of M-AAT, which is protective of lung function, and reduced mutant Z-AAT, a cause of liver disease.

Check out renal FDA news and new research on pediatric kidney stone management, CKD trends, spironolactone for dialysis patients, and more.

Check out expert perspectives on unmet needs and advances in gastroparesis and new research on C. diff, IBS, and more in this August 2025 recap.

Check out expert perspectives on semaglutide’s FDA approval for MASH and new research on PBC, infectious disease screening, and more in this August 2025 recap.

Vancomycin was linked to a higher risk of acute kidney injury than alternative antibiotics, underscoring the need for appropriate prevention strategies.