The HCPFive: Top News for Healthcare Providers from the Week of 09/28

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 (FDA) approvals of guselkumab (Tremfya) for pediatric plaque psoriasis (PsO) and psoriatic arthritis (PsA) and remibrutinib (Rhapsido) for chronic spontaneous urticaria (CSU), 2 regulatory submissions from Novo Nordisk for insulin icodec (Awiqli) injection for type 2 diabetes and denecimig (Mim8) for hemophilia A, and phase 3 data for evolocumab (Repatha) in patients with atherosclerotic cardiovascular disease (ASCVD).

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 September 28, 2025—let’s jump in!

FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis

On September 29, 2025, the FDA approved Johnson & Johnson’s guselkumab (Tremfya) for the treatment of children ≥ 6 years of age who also weigh ≥ 40 kg (88 lbs) with moderate to severe PsO, who are candidates for systemic therapy or phototherapy, or active PsA. The decision makes guselkumab the first and only IL-23 inhibitor approved for these pediatric indications.

FDA Approves Remibrutinib for Chronic Spontaneous Urticaria

On September 30, 2025, the FDA approved Novartis’ remibrutinib (Rhapsido), a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, for adults with CSU. The decision was supported by data from the phase 3 REMIX-1 and REMIX-2 trials showing that remibrutinib produced early and substantial reductions in CSU symptoms, with improvements sustained for up to 52 weeks.

Novo Nordisk Resubmits Insulin Icodec (Awiqli) Injection BLA for Type 2 Diabetes

On September 29, 2025, Novo Nordisk announced the resubmission of its Biologics License Application (BLA) to the FDA for insulin icodec (Awiqli) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes. The resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program and follows a July 2024 CRL over concerns regarding the manufacturing process and the type 1 diabetes indication.

Novo Nordisk Submits Denecimig (Mim8) BLA for Hemophilia A

On September 29, 2025, Novo Nordisk announced the submission of a Biologics License Application (BLA) for denecimig (Mim8) as a prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital FVIIIa deficiency), with or without inhibitors. The submission was supported by results from the FRONTIER study program.

VESALIUS-CV: Evolocumab (Repatha) Achieves Primary Endpoints in Patients with ASCVD

On October 2, 2025, Amgen announced positive results from the phase 3 VESALIUS-CV trial of evolocumab (Repatha) in patients with ASCVD and no prior history of heart attack or stroke. The trial met its dual primary endpoints for time to first occurrence of a composite of heart attack, ischemic stroke, and coronary heart disease (CHD) death, as well as time to first occurrence of a composite of CHD death, ischemic stroke, heart attack, or any ischemia-driven arterial revascularization.