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Monday, September 29, 2025

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

 The US Food and Drug Administration has 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 plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA).1

According to a September 29, 2025, press release from the Company, the decision makes guselkumab the first and only IL-23 inhibitor approved for these pediatric indications and builds on the initial FDA approvals in adults living with moderate to severe plaque PsO in 2017 and active PsA in 2020.

https://www.hcplive.com/view/fda-approves-guselkumab-tremfya-for-pediatric-plaque-psoriasis-psoriatic-arthritis

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