The HCPFive: Top News for Healthcare Providers from the Week of 10/26

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration approvals of an updated indication for sotatercept-csrk (Winrevair) in adults with pulmonary arterial hypertension (PAH) and a single-injection once-monthly maintenance regimen of mirikizumab-mrkz (Omvoh) for adult patients with ulcerative colitis as well as new data demonstrating mazdutide’s superiority to semaglutide for type 2 diabetes and obesity, an association between neutrophil-to-lymphocyte ratio (NLR) levels and reduced renal function in patients with IgA nephropathy, and the prevalence of gluten or wheat sensitivity among people without celiac disease.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of October 26, 2025—let’s jump in!

FDA Approves Updated Indication for Sotatercept-csrk (WINREVAIR) in Adult PAH

On October 27, 2025, the FDA approved an updated indication for sotatercept-csrk (Winrevair) in adults with PAH based on results from the phase 3 ZENITH study. This randomized, double-blind, placebo-controlled trial investigated adding sotatercept-csrk to background therapy, with findings demonstrating a statistically significant and clinically meaningful reduction in major morbidity and mortality outcome risk in adults with PAH World Health Organization (WHO) functional class (FC) III or IV compared to placebo.

FDA Approves Single-Dose Formulation of Mirikizumab-mrkz for Ulcerative Colitis

On October 27, 2025, the FDA approved mirikizumab-mrkz (Omvoh) as a single-injection once-monthly maintenance regimen for adult patients with ulcerative colitis based on results from a phase 1 study comparing 1 200 mg/2 mL subcutaneous injection to 2 100 mg/1 mL injections. The study confirmed the bioequivalence of the new 1-dose treatment to the previously approved 2-dose regimen.

Mazdutide Demonstrates Superiority to Semaglutide in Type 2 Diabetes and Obesity

On October 26, 2025, Innovent Biologics announced that its investigative GLP-1/glucagon (GCG) dual receptor agonist mazdutide met its primary endpoint of superiority to semaglutide in HbA1c and body weight reduction in patients with type 2 diabetes and comorbid obesity. DREAMS-3 was the fourth in a series of phase 3 clinical trials investigating mazdutide, with results showing a significantly greater proportion of participants achieved HbA1c <7% and a ≥10% body weight reduction from baseline at week 32 in the mazdutide group compared to semaglutide.

High Neutrophil-To-Lymphocyte Ratio Linked to Early Renal Function Decline in IgAN

Recent research points to a significant association between elevated NLR levels and reduced renal function in patients with IgA nephropathy. In the study, IgAN patients with higher NLR levels exhibited more severe clinical manifestations. Further analysis revealed a high NLR may be associated with an increased risk of eGFR ≤ 60 mL/min·1.73 m2 in this patient population.

1 in 10 People Without Celiac Disease Report Gluten or Wheat Sensitivity

Findings from this systematic review and meta-analysis suggest about 1 in 10 people worldwide self-report non-celiac gluten/wheat sensitivity, with a female predominance and a significant association with psychological distress and irritable bowel syndrome, suggesting that non-celiac gluten/wheat sensitivity should be positioned within the spectrum of disorders of gut–brain interaction once organic pathologies have been excluded.