Johnson & Johnson seeks FDA approval for its ulcerative colitis treatment
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- Johnson & Johnson (NYSE:JNJ) announced submission of a supplemental Biologics License Application to the U.S. FDA seeking approval of a subcutaneous induction regimen of TREMFYA for the treatment of adults with moderately to severely active UC.
- The filing is supported by data from the Phase 3 ASTRO study of TREMFYA SC induction therapy in adults with UC and builds upon the recent U.S. approval of TREMFYA in this indication.
- Source: Press Release