DailyMed
Cure8 regulatory brief
Why This Matters
This label update affects people with IBD because golimumab (SIMPONI) is an approved anti‑TNF treatment for ulcerative colitis and the label includes safety changes and pediatric dosing information that could affect treatment decisions.
Who Should Pay Attention
Adults and pediatric patients with ulcerative colitis, caregivers, and clinicians who prescribe or manage biologic therapy for IBD
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Source depthMetadata only
What To Know
This DailyMed entry is an updated prescribing information (label) for SIMPONI (golimumab).
It lists approved indications including ulcerative colitis, dosing for adults and pediatric patients ≥15 kg, boxed warnings about serious infections and malignancy, and warnings/precautions including TB testing, HBV reactivation, and contraindications for live vaccines. The label revision date shown is 10/2025.
Keep In Mind
DailyMed provides the official FDA-approved prescribing information; the document is a regulatory label update and does not present new clinical trial results. Patients should consult their clinician for how label changes affect individual care.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Evidence type derived from source or registry metadata.
PublicationDailyMed
Study typeDrug Label Update
Indexed viaDailyMed
Source typeDrug label record
PublishedSep 24, 2026, 12:00 AM
Content availableMetadata only
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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