Subcutaneous guselkumab showed significant clinical remission and endoscopic response in moderate to severe Crohn's disease, with no added safety concerns. The GRAVITI study supported guselkumab's ...

The FDA expanded the approval of guselkumab (Tremfya) to include treatment of moderately to severely active Crohn's disease, drugmaker Johnson & Johnson announced on Thursday. An interleukin (IL ...

The US Food and Drug Administration (FDA) approved guselkumab (Tremfya, Johnson & Johnson) for the treatment of adults with moderate to severe active Crohn’s disease (CD). The approval marks the ...

Guselkumab is the first IL-23 inhibitor approved for Crohn's disease with subcutaneous and intravenous options, targeting inflammation by blocking IL-23 and binding to CD64. The GRAVITI study ...

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya) for the treatment of Crohn’s disease and ulcerative colitis (UC). Already used for plaque psoriasis and ...

Tremfya is the only IL-23 inhibitor with IV and SC induction options for treating Crohn disease. The Food and Drug Administration (FDA) has approved Tremfya ® (guselkumab) for the treatment of ...

TREMFYA ® is the only IL-23i to show superiority versus STELARA ® in all pooled endoscopic endpoints within a double-blinded registrational trial TREMFYA ® approval in Crohn's disease ...

However, clinical studies have shown that guselkumab is also efficacious in treating adults with moderately to severely active Crohn’s disease and UC who have not responded well to other ...