Abigail Brooks, MA

Recent FDA approvals of pegcetacoplan and iptacopan revolutionize C3 glomerulopathy treatment, offering hope and targeted options for patients.

Check out expert perspectives and new research on hepatitis C, cirrhosis, and more in this July 2025 recap.

This FDA News Month in Review provides a round-up of regulatory decisions from July 2025.

From clinical trial updates in IBD to novel research about IBS and other disorders of gut brain interaction, catch up on the latest headlines in GI.

Inclisiran can now be used alone, without addition of statin therapy, as adjunct to diet and exercise for LDL-C reduction in hypercholesterolemia.

Findings confirm a significant post-pandemic rise in disorders of gut-brain interaction, including IBS and functional dyspepsia.

Tirzepatide was non-inferior to dulaglutide with an 8% lower rate of MACE-3 events while delivering greater reductions in A1C and weight.

Topline results from the first of 2 studies in the UP-AA program show upadacitinib 15 mg and 30 mg met the primary endpoint for scalp hair coverage.

Findings suggest 7000 steps per day is associated with a reduced risk of health outcomes including mortality, cardiovascular disease, and type 2 diabetes.

Study findings suggest significant sex disparities in liver complication risk among adult patients with cirrhosis, especially in the context of nonviral cirrhosis.

FDA approves pegcetacoplan (Empaveli) for treating C3 glomerulopathy and primary IC-MPGN, offering hope for patients aged 12 and older.

The approval was based on positive results from the phase 3 foresiGHt trial and expands upon the indication for pediatric growth hormone deficiency.

Positive topline results showed obefazimod met its primary endpoint for clinical remission at week 8 in the 50 mg dose cohort in ABECT-1 and ABECT-2.

Findings showed GLP-1 RAs reduced the risk of overall dementia, particularly Alzheimer’s disease and non-vascular dementias, compared with metformin.

Study findings showed IBS patients with self-perceived gluten sensitivity reacted similarly to gluten, wheat, and sham challenges.

In CKD patients with COVID-19, prior vaccination significantly reduced risks of major adverse kidney events and mortality, especially with ≥ 3 doses.

Nearly 13 million people received DAA treatment in the last 10 years, representing 21% of the starting 62 million people with chronic HCV and 30% of the target population.

The most effective FMT strategy involved giving FMT as multiple-dose capsules or colonoscopy after an extended period of antibiotic pretreatment.

Patients who adhered to a strict 12-week low FODMAP diet saw improvements in fatigue, anxiety, and depression, and performed better on an attention test.

Moderate vitamin D deficiency was not associated with cognitive outcome risk, but severe deficiency was linked to both cognitive impairment and mortality.

Female sex and recent pregnancy were independent risk factors for reduced likelihood of DAA prescription among people with HCV entering opioid use disorder treatment.

Sarcopenia was most prevalent among those on hemodialysis, but prevalence varied based on assessment criteria and timing of lean muscle mass measurement.

Treatment with baxdrostat resolved or reduced the severity of hypertension, excessive aldosterone production, and hypokalemia in the phase 2a SPARK trial.

Study findings highlight the cost-effectiveness of more frequent HCV testing among people who inject drugs compared with no testing and less frequent testing.

Nontargeted screening identified more HCV infections than targeted screening, but both approaches led to minimal linkage to care and SVR12.

Actual LLT use was significantly lower than the proportion of guideline-eligible patients for statins, ezetimibe, and PCSK9i.

The initial batch of published CRLs are associated with since-approved applications in an effort to increase transparency and provide insight into the decision-making process.

The prespecified analysis of FINEARTS-HF found finerenone’s impact on HF events, cardiovascular death, and symptoms was not impacted by frailty.

The first half of 2025 recap for nephrology spotlights renal FDA action, ERA 2025 Congress coverage, and updates in xenotransplantation.

The first half of 2025 recap for gastroenterology spotlights GI FDA approvals, clinical trial data, and new guidance on bowel preparation for colonoscopy.