GENEVA, Switzerland — Johnson & Johnson (NYSE: JNJ) today announced new data across 12 abstracts at the European Academy of Neurology (EAN) 2026 Congress that offer additional insight into the use of IMAAVY® (nipocalimab-aahu) throughout clinically relevant points in the generalized myasthenia gravis (gMG) treatment journey. The analyses include adults with anti-AChRa or...
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RARITAN, N.J. — Johnson & Johnson (NYSE:JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for subcutaneous amivantamab and hyaluronidase-lpuj for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). If approved, it would provide a...
RARITAN, N.J. — Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced positive topline results from the investigational Phase 3 MajesTEC-9 study of TECVAYLI® (teclistamab-cqyv) monotherapy, showing a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death in a...
SPRING HOUSE, Pa. — Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the Phase 2b JASMINE (NCT04882878) study of adults living with systemic lupus erythematosus (SLE) and the initiation of a Phase 3 program. The JASMINE study met the primary endpoint (percentage of patients achieving Systemic Lupus Erythematosus Responder...
SPRING HOUSE, Pa. — Johnson & Johnson today announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG) as well as the Phase 2 DAHLIAS study of nipocalimab in adults with Sjögren’s disease (SjD). Nipocalimab has demonstrated clinical effect in...
SPRING HOUSE, Pa. — 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 IMAAVY® (nipocalimab-aahu) as the first-ever treatment for patients with warm autoimmune hemolytic anemia (wAIHA).b This rare and serious autoantibody disease affects...
SPRING HOUSE, Pa. — Johnson & Johnson (NYSE: JNJ) today announced that nipocalimaba was granted U.S. Food and Drug Administration (FDA) Fast Track designation as a potential treatment for adults with systemic lupus erythematosus (SLE), a debilitating autoantibody-driven disease that impacts approximately 3 to 5 million people worldwide.1 The U.S. FDA’s Fast...
TAR-200 monotherapy shows highest complete response with sustained benefits in 12-month data from Phase 2b SunRISe-1 study (Cohort 2) Compelling first results from Cohort 4 of Phase 2b SunRISe-1 study show potential of TAR-200 monotherapy in patients with papillary-only, high-risk non-muscle invasive bladder cancer RARITAN, N.J. — Johnson...
PRING HOUSE, Pa. — Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) approval of IMAAVY® (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) – a rare, life-threatening autoantibody disease – in adults and pediatric patients 12 years of age and older currently or previously...
HORSHAM, PA. — Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and...