Abigail Brooks, MA

The month in review spotlights renal regulatory news and clinical trial data as well as coverage of the 62nd European Renal Association Congress.

The month in review spotlights hepatic regulatory news, new clinical trial data, and novel research about liver disease risk factors.

The month in review spotlights perspectives on collaborative GI care, updates in C diff, and new research about disorders of gut brain interaction.

The CRL cited deficiencies previously identified at a third-party manufacturing vendor unrelated to OLC, and the Company plans to request a Type A meeting.

Patients with cirrhosis receiving diuretics and SGLT-2 inhibitors experienced lower rates of serious liver events than those not taking SGLT-2 inhibitors.

The analysis of Rome Foundation Global Epidemiology Study data identified 4 dietary pattern clusters linked to variations in the global prevalence and severity of IBS.

Positive topline results show the trial met its primary endpoint for MASH resolution and fibrosis improvement, with significant weight loss effects without plateauing.

Topline data from the phase 1b study for the final 400 mg dose cohort demonstrate favorable safety, tolerability, and pharmacokinetics similar to the 150 mg dose cohort.

Despite adequate adherence to a gluten-free diet and declining TTG IgA values, 43% of the pediatric celiac disease patients met Rome IV diagnostic criteria for DGBI.

More frequently adding salt to food was associated with heightened risks of MASLD, cirrhosis, and hepatocellular carcinoma.

While achieving SVR was linked to improvements in fibrosis markers, hepatic steatosis prevalence increased, especially in those with metabolic dysfunctions.

Patients with alcohol-associated liver disease and MetALD had greater risks of adverse liver outcomes and all-cause mortality than those with MASLD.

Phase 4 data highlight dupilumab’s superiority to omalizumab for all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints.

With the FDA acceptance of the NDA, the agency has assigned a PDUFA target action date of January 31, 2026, and may require an Advisory Committee meeting for approval.

Systematic review and meta-analysis findings support recent guidelines advising against short-acting beta-agonist monotherapy for asthma management.

Phase 3 trial results show FMT was noninferior to standard-of-care vancomycin for patients with a first episode of C diff infection.

Findings highlight an increased risk of MASLD, heart failure, type 2 diabetes, and other cardiometabolic diseases following cycles of weight loss and regain.

Study findings highlight a heightened risk of MetS in patients with psoriasis, especially those with more severe disease based on PASI scores.

A high alopecia areata burden was seen among US Asian and Pacific Islander children, particularly South Asian, Filipino, Vietnamese, and Native Hawaiian/Pacific Islander subgroups.

Successful HCV treatment with DAAs was associated with reduced risks of CKD, stroke, major adverse cardiac events, and neurocognitive disorders.

Use of an AI-guided infection prevention bundle did not significantly reduce CDI incidence but was associated with increased antimicrobial stewardship.

The label expansion makes glecaprevir/pibrentasvir the first and only oral 8-week pangenotypic treatment option approved for people with acute or chronic HCV.

Mortality from ALD rose significantly across most demographic groups in the US from 1999 to 2022, especially during and following the COVID-19 pandemic onset.

Patients with SCAD and comorbid depression had greater rates of heart failure, cerebrovascular disease, acute kidney injury, and atrial fibrillation.

The pooled analysis of BROOKLYN and BROADWAY data outline obicetrapib’s impact on HbA1c reduction and a trend toward lower new-onset diabetes risk.

Study findings highlight the potential utility of cardiac catheterization as a targeted intervention in pre-kidney transplant cardiac risk stratification.

Compared to age-matched controls, women with premature menopause had greater risks of all-cause mortality and multiple cardiovascular complications.

The month in review spotlights hepatic podcast episodes from HCPLive, new clinical trial data, and coverage from DDW.

View conference highlights from HCPLive’s coverage of the American Thoracic Society (ATS) International Conference 2025.

With the priority review acceptance of the Biologics License Application, the FDA has assigned a PDUFA target action date of November 28, 2025.