Johnson & Johnson submits application seeking US FDA approval of Simponi (golimumab) for the treatment of paediatric ulcerative colitis

Johnson & Johnson

16 December 2024 - Submission aims to expand Simponi ulcerative colitis indication to include paediatric population.

Johnson & Johnson today announced the submission of a supplemental biologics license application to the US FDA seeking expanded approval of Simponi (golimumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis.

Read Johnson & Johnson press release

Michael Wonder

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Michael Wonder

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Medicine , US , Paediatrics , Dossier