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Johnson & Johnson Seeks FDA Approval for Subcutaneous Induction Regimen of TREMFYA

The filing is supported by data from the Phase 3 ASTRO study of TREMFYA SC induction therapy in adults with UC.

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By: Charlie Sternberg

Associate Editor

Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a subcutaneous (SC) induction regimen of TREMFYA (guselkumab) 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.   The Phase 3 ASTRO study m...

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