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SPRING HOUSE, PA — The U.S. Food and Drug Administration (FDA) has granted Priority Review to Johnson & Johnson’s Biologics License Application (BLA) for nipocalimab, a treatment for generalized myasthenia …
Johnson & Johnson’s Nipocalimab Receives FDA Priority Review for Generalized Myasthenia Gravis Read More SPRING HOUSE, PA — Johnson & Johnson has submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA), aiming to expand the use of TREMFYA® (guselkumab) …
Johnson & Johnson Seeks FDA Approval to Expand TREMFYA® Use for Pediatric Conditions 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) seeking approval for a subcutaneous (SC) …
Johnson & Johnson Advances Ulcerative Colitis Treatment with FDA Filing for TREMFYA® Subcutaneous Regimen Read More SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) has announced encouraging results from its Phase 3 investigational study of icotrokinra (JNJ-2113), a groundbreaking oral peptide designed to selectively block …
Johnson & Johnson Reports Promising Results for Psoriasis Treatment Study Read More 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