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Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Jun 06, 2023 United States Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival (PFS) CARTITUDE-4 is the first randomized Phase 3 study investigating the ...
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 ...
Johnson & Johnson to Acquire Proteologix, Inc. to Lead in Atopic Dermatitis Treatment
May 16, 2024 Acquisition advances Johnson & Johnson’s leading Dermatology portfolio with opportunity to address significant unmet need in atopic dermatitis (AD) Includes bispecific antibodies targeting proven disease pathways and offers the potential ...
World Mental Health Day: An Opportunity to Reflect on Global Challenges
Reflecting on World Mental Health Day Dr. Chantharavady Choulamany Every year, World Mental Health Day on October 10 provides an opportunity to address, as a global community, one of the greatest personal, medical, and economic challenges of our time: the ...
U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma
Mar 15, 2024 United States FDA ODAC unanimously votes 11 to 0 supporting favorable risk-benefit assessment of CARVYKTI® based on results from the Phase 3 CARTITUDE-4 study RARITAN, N.J., March 15, 2024 – Johnson & Johnson announced today that the U.S. ...
Innovations in the Interception of Lung Cancer: How a Smartphone App May Aid Smoking Cessation in China
Innovations in the Interception of Lung Cancer: How a Smartphone App May Aid Smoking Cessation in China Many risk factors of lung cancer are known, and its pre-malignant state continues to emerge through insights in genetic markers, disease heterogeneity ...
TREMFYA® (guselkumab) demonstrates superiority versus STELARA® (ustekinumab) in Phase 3 Crohn's disease program
May 23, 2024 Data from GALAXI 2 & 3 showed TREMFYA® was superior to STELARA® in all pooled endoscopic endpoints Washington, D.C. (May 21, 2024) – Johnson & Johnson today announced the first Phase 3 results for TREMFYA® (guselkumab) in adult ...
TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease
Sep 11, 2024 United States The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA ® showed highly statistically significant rates of endoscopic remission at one year in the pivotal QUASAR program [1], [2], ...
European Commission Approves TALVEY®▼ (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Aug 22, 2023 Belgium Talquetamab, the first bispecific antibody targeting GPRC5D, showed an overall response rate of more than 70 percent with durable responses, including responses achieved by over 60 percent of patients with prior T-cell redirection ...
TREMFYA® (guselkumab) Real-World Data Analyses Show Greater Treatment Persistence Than IL-17s in Both Bio-naïve and Bio-experienced Patients Living With Moderate to Severe Plaque Psoriasis
Mar 17, 2023 United States Additional post-hoc analysis of TREMFYA showed improvements in scalp psoriasis and quality-of-life measures at week 48 SPRING HOUSE, PENNSYLVANIA, March 17, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson ...