Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!



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Top 5 Healthcare Headlines for September 28-October 4, 2025:



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



The FDA approved guselkumab as the first IL-23 inhibitor for children ≥6 years with moderate-to-severe plaque psoriasis or active psoriatic arthritis.



FDA Approves Remibrutinib for Chronic Spontaneous Urticaria



Remibrutinib, a selective BTK inhibitor, gained FDA approval for adults with chronic spontaneous urticaria based on sustained efficacy in phase 3 trials.



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



Novo Nordisk resubmitted its once-weekly insulin icodec BLA for type 2 diabetes after addressing prior FDA concerns.



Novo Nordisk Submits Denecimig (Mim8) BLA for Hemophilia A



Novo Nordisk filed a BLA for denecimig as prophylaxis for hemophilia A, supported by FRONTIER program data.



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



Evolocumab reduced major cardiovascular events in ASCVD patients without prior MI or stroke in the phase 3 VESALIUS-CV trial.