Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active Crohn's disease. This marks the second submission to the FDA for TREMFYA® in inflammatory bowel disease this year following an application in March for moderately to severely active ulcerative colitis.a
Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn's disease.1 The study met both co-primary endpoints, achieving statistically significant and clinically meaningful outcomes for clinical remission at Week 12 as well as endoscopic response at Week 12. All remaining multiplicity-controlled secondary endpo
In the last year, many Johnson & Johnson ( NYSE:JNJ ) insiders sold a substantial stake in the company which may have...