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...
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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...
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...
ORLANDO, Fla. — Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma, today announced new data from the investigational Phase 3 MajesTEC-3 study that demonstrate the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as early as second line for patients with relapsed/refractory multiple myeloma (RRMM). Results show an 83% reduction in...
SPRING HOUSE, Pa. — Johnson & Johnson Family of Companies today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nipocalimab for the treatment of alloimmunizeda pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN). Nipocalimab is currently...
Boston –The José Baselga Research Fund (JBRF), supported by Alexion, AstraZeneca Rare Disease, announced the initiation of the Global José Baselga Research Grant (Baselga Grant), an annual $75,000 grant to advance the treatment of prion diseases, a group of rare progressive neurodegenerative disorders. “Our family feels incredibly lucky to have...
Badalona, Spain – Multiple myeloma is a type of blood cancer that appears mainly after the age of sixty. Its incidence, therefore, increases with the aging of the population. In this pathology, the bone marrow, the porous structure within the bones that produces normal blood cells, is invaded by an...
BEDMINSTER, N.J. – Jubilant Therapeutics Inc, a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of the investigational new drug application (IND) for JBI-802, a novel, oral, potent and selective dual inhibitor...