Janssen-Cilag International NV, a Johnson & Johnson company, today announced it has submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.
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This positive CHMP opinion establishes amivantamab as a new option, and the first fully-human EGFR-MET bispecific antibody, in the first-line treatment of.