Johnson & Johnson (JNJ) Gains FDA Nod for TREMFYA Subcutaneous Therapy

Johnson & Johnson (NYSE:JNJ) ranks among the top picks for a retirement portfolio. On September 26, Johnson & Johnson reported that the US FDA had approved a subcutaneous induction protocol of TREMFYA (guselkumab) for the treatment of individuals with moderate to severe active ulcerative colitis. With this approval, TREMFYA becomes the first IL-23 inhibitor to provide both subcutaneous and intravenous induction alternatives for UC and Crohn’s disease medication.

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The Phase 3 ASTRO trial’s findings served as the foundation for the approval. In comparison to patients receiving a placebo, a considerably higher percentage of patients receiving TREMFYA 400 mg subcutaneously every four weeks experienced clinical remission and endoscopic improvement at Week 12.

Johnson & Johnson was previously approved by the FDA in September 2024 for TREMFYA with intravenous induction for ulcerative colitis, and in March 2025 for both subcutaneous and intravenous induction methods to treat Crohn’s disease.

Johnson & Johnson is a notable name in the healthcare industry, which includes sub-sectors like pharmaceuticals, medical equipment, and consumer health products. The company is known for creating medications to treat a variety of conditions and diseases, including cancer, diabetes, and HIV/AIDS.

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This article is originally published at Insider Monkey.