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SPRING HOUSE, PA — Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to nipocalimab for treating adults with moderate-to-severe Sjögren’s …
FDA Grants Breakthrough Therapy Designation to Johnson & Johnson’s Nipocalimab for Sjögren’s Disease Read More HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) has announced the FDA‘s approval of TREMFYA® (guselkumab) for adults with moderately to severely active ulcerative colitis (UC). This chronic inflammatory condition affects …
FDA Approves TREMFYA® for Ulcerative Colitis Treatment, Promising New Hope for Patients Read More SPRING HOUSE, PA — Johnson & Johnson has taken a significant step forward in addressing generalized myasthenia gravis (gMG) by submitting a Biologics License Application to the FDA for nipocalimab. …
Johnson & Johnson Seeks FDA Approval for Pioneering Myasthenia Gravis Treatment Read More SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) has announced encouraging results from the Phase 2 UNITY study evaluating nipocalimab for treating pregnant individuals at risk of early onset …
Johnson & Johnson Announces Promising Phase 2 Study Results for Nipocalimab in Treating Severe HDFN Read More HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) recently approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and …
FDA Approves DARZALEX FASPRO® for Newly Diagnosed Multiple Myeloma Patients Read More SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of TREMFYA® …
Johnson & Johnson Seeks FDA Approval for TREMFYA in Treating Crohn’s Disease Read More SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) revealed encouraging topline results from its Phase 3 GRAVITI study on TREMFYA® (guselkumab) subcutaneous (SC) induction therapy for adults with moderate …
Johnson & Johnson Reports Positive Results for New Crohn’s Disease Treatment Read More