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Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA® (guselkumab) for treatment of patients with ulcerative colitis and Crohn's disease
May 01, 2024 Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI program in Crohn’s disease, which each achieved their primary endpoints [1], [2] Beerse, Belgium (May 1, 2024) – Janssen-Cilag International ...
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer
Aug 20, 2024 United States RYBREVANT ® plus LAZCLUZE™ is the first and only chemotherapy-free regimen showing superior progression-free survival versus osimertinib Following Priority Review, approval is based on Phase 3 MARIPOSA results showing RYBREVANT ...
Dexamethasone reduces infusion-related reactions in patients with EGFR-mutated non-small cell lung cancer treated with intravenous RYBREVANT® (amivantamab-vmjw)
Sep 10, 2024 United States Pre-medication regimen showed an infusion-related reaction rate of 22.5 percent with intravenous RYBREVANT ®, a three-fold reduction from 67.4 percent historically seen with standard IRR management SAN DIEGO, CA, September 10, ...
Janssen Submits Type II Extension of Indication Application to the European Medicines Agency Seeking Approval of RYBREVANT®▼ (amivantamab), in combination with Lazertinib, for First-Line Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer
Feb 08, 2024 Belgium The submission is supported by data from the Phase 3 MARIPOSA study, showing statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with ...
Janssen Highlights Latest Research for TREMFYA® (guselkumab) and Investigational Targeted Oral Peptide JNJ-2113 in Moderate to Severe Plaque Psoriasis at the European Academy of Dermatology and Venereology (EADV) Congress
Oct 09, 2023 United States 30 presentations showcase breadth of data from Janssen’s Immunodermatology pipeline across five commercialized and investigational therapies SPRING HOUSE, PENNSYLVANIA, October 9, 2023 – Janssen Pharmaceuticals, Inc., a ...
Johnson & Johnson reports positive topline results for nipocalimab from a Phase 3 pivotal study in generalized myasthenia gravis (gMG) and a Phase 2 study in Sjögren’s Disease (SjD)
Feb 05, 2024 United States Nipocalimab showed clinical efficacy in gMG, a chronic debilitating autoantibody disease where significant unmet patient need exists for efficacious, safe therapies that offer sustained disease control Nipocalimab is the first ...
Janssen Seeks European Commission Approval of a New Indication for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) for the Earlier Treatment of Patients with Relapsed and Refractory Multiple Myeloma
May 25, 2023 Belgium Application to the European Medicines Agency is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the safety profile and efficacy of cilta-cel in the treatment of patients who received one to three prior lines of ...
Johnson & Johnson seeks first approval of nipocalimab to treat broadest population living with antibody positive generalized myasthenia gravis
Aug 29, 2024 United States Marks first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce levels of autoantibodies Filing based on the Phase 3 Vivacity-MG3 program, the ...
Johnson & Johnson is transforming solid tumor cancer outcomes with new data at the 2024 World Conference on Lung Cancer and European Society for Medical Oncology Congress
Aug 27, 2024 United States Four RYBREVANT ® (amivantamab-vmjw) studies feature compelling new findings in lung and colorectal cancers New TAR-200 data reveal the potential of organ-sparing therapy for the treatment of bladder cancer RARITAN, NJ, August ...
Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Lazertinib, in combination with RYBREVANT®▼ (amivantamab), for the First-Line Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer
Dec 21, 2023 Belgium The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress [1] Lazertinib is a highly selective, central nervous system-penetrant, ...