The HCPFive: Top News for Healthcare Providers from the Week of 11/16

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 acceptance of a supplemental New Drug Application (sNDA) for roflumilast (Zoryve) cream 0.3% in children aged 2-5 years with psoriasis and the approval of plozasiran (Redemplo) for the reduction of triglycerides in adult patients with familial chylomicronemia syndrome (FCS), new American Gastroenterological Association (AGA) clinical practice guidelines on the pharmacologic management of moderate-to-severely active Crohn’s disease (CD), and phase 3 data on telitacicept in IgA nephropathy and tralokinumab in adults with atopic dermatitis and moderate-to-severe hand involvement.

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 November 16, 2025—let’s jump in!

FDA Accepts sNDA for Roflumilast Cream 0.3% in Children Ages 2 to 5 with Psoriasis

On November 17, 2025, the FDA accepted Arcutis Biotherapeutics’ sNDA for roflumilast (Zoryve) cream 0.3% in children 2-5 years of age with psoriasis, assigning a PDUFA target action date of June 29, 2026. The sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2-5 years with plaque psoriasis, as well as data from a long-term open-label study that included children in that age range.

FDA Approves Plozasiran for Adults With Familial Chylomicronemia Syndrome

On November 18, 2025, the FDA approved Arrowhead Pharmaceuticals’ plozasiran (Redemplo) for the reduction of triglycerides in adult patients with FCS, making it the first and only FDA-approved siRNA medicine for people living with FCS. The decision was supported by clinical data from the phase 3 PALISADE study.

AGA Releases Updated Clinical Crohn’s Disease Guideline Reflecting New Therapies

On November 20, 2025, the AGA released a living clinical practice guideline on the pharmacologic management of moderate-to-severely active CD, intended to support a comprehensive, patient-centered, evidence-based approach to managing this patient population. The document includes 16 recommendations emphasizing early use of high-efficacy therapies including infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, and upadacitinib over step-up treatment to improve patient outcomes.

Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study

New phase 3 data show that in patients with IgAN at high risk of progression, treatment with telitacicept for 39 weeks resulted in a rapid, substantial, and statistically significant reduction in proteinuria compared with placebo, with a favorable safety profile. The investigational recombinant fusion protein enters a rapidly evolving therapeutic landscape in IgAN, where multiple B-cell–, BAFF-, and APRIL-targeted approaches are under active clinical investigation.

Tralokinumab Improves Atopic Dermatitis with Hand Involvement at 32 Weeks

On November 17, 2025, LEO Pharma A/S announced positive topline key findings on tralokinumab in adults with atopic dermatitis and moderate-to-severe hand involvement who are also candidates for systemic treatments. Findings from the 32-week analysis of the phase 3b ADHAND trial evaluating patients with atopic dermatitis and disease involvement affecting the hands build upon previous week 16 findings demonstrating statistically significant improvement compared to placebo in all primary and key secondary endpoints such as clear or almost clear skin, itch, and pain.