Abigail Brooks, MA

The accelerated approval is based on findings from Part 1 of the ESSENCE trial and indicates the agent for noncirrhotic MASH with moderate to advanced fibrosis.

Stone clearance was similar with ureteroscopy vs shockwave lithotripsy, but the latter was associated with better recovery and patient-reported outcomes.

Findings highlight an association between psoriasis and risks of all-cause, cardiovascular, infection-related, and suicide mortality.

Providing nurses and MAs with an educational video on standardized hair loss photo techniques increased the quantity and quality of documented pictures.

The global burden of CKD attributable to high BMI has shown a consistent upward trend from 1990 to 2021, with projections further increases by 2050.

The FDA approved generic versions of Venofer (iron sucrose) injection from Viatris Inc and Amphastar Pharmaceuticals.

C difficile carriers had greater baseline hazard for hospital-onset infection than non-carriers, with risk not significantly affected by antibiotic exposure.

Findings from the IBS in America Survey suggest IBS symptoms disrupt patients’ productivity and personal activities 19 days each month.

Co-locating ID screening in an inpatient SUD program resulted in timely identification of and linkage to care for viral hepatitis and latent tuberculosis.

The once-daily oral GLP-1 RA met the primary endpoint for body weight reduction at 72 weeks and demonstrated improvements in cardiovascular risk factors.

Check out the latest renal regulatory news, clinical trial data, and nephrology research in this July 2025 recap.

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.