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HORSHAM, Pa. — Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule* for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj). When administered in combination with oral LAZCLUZE® (lazertinib) for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC), monthly...
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...
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...