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October 24, 2025 08:02 ET | Source: Janssen Cilag International NV

TREMFYA® (guselkumab) receives European Commission approval for subcutaneous induction through to maintenance in adults with ulcerative colitis, now the first IL-23 inhibitor with a fully subcutaneous dose regimen

Guselkumab offers the flexibility of self-administration from the start of treatment in both ulcerative colitis (UC) and Crohn’s disease (CD),1,2,3 providing the simplicity of a fully subcutaneous...
September 19, 2025 10:10 ET | Source: Janssen Cilag International NV

TREMFYA (guselkumab) receives positive CHMP opinion for subcutaneous induction regimen in ulcerative colitis, a first for an IL-23 inhibitor

Recommendation based on the findings from the Phase 3 ASTRO study in ulcerative colitis.1,2,3 Guselkumab has the potential to become the first IL-23 inhibitor to offer both subcutaneous and...
September 11, 2025 07:56 ET | Source: Janssen Cilag International NV

Johnson & Johnson seeks first European Medicines Agency approval for icotrokinra aiming to transform the plaque psoriasis treatment paradigm

Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor.1 Filing based on four Phase 3 studies that met all primary and co-primary endpoints....
July 29, 2025 13:51 ET | Source: Spherix Global Insights

Hematologist Dissatisfaction with Current Warm Autoimmune Hemolytic Anemia (w-AIHA) Treatment Spurs Interest in Late-Stage Pipeline, According to Spherix Global Insights

EXTON, PA, July 29, 2025 (GLOBE NEWSWIRE) -- According to new findings from Spherix Global Insights’ syndicated Market Dynamix™ service, hematologists managing patients with warm autoimmune...
July 23, 2025 05:30 ET | Source: Janssen Cilag International NV

European Commission approves DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma

Landmark approval is based on results from the Phase 3 AQUILA study, showing fixed-duration treatment with daratumumab significantly reduced the risk of progression to active multiple myeloma or death...
July 23, 2025 05:06 ET | Source: Janssen Cilag International NV

European Commission approves IMBRUVICA® (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant

Ibrutinib is the first approved Bruton’s tyrosine kinase (BTK) inhibitor to demonstrate statistically meaningful outcomes versus autologous stem cell transplant (ASCT) for the frontline treatment of...
June 12, 2025 02:00 ET | Source: Janssen Cilag International NV

Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison

Cross-study findings indicate significant clinical benefit of frontline fixed-duration ibrutinib plus venetoclax with improved likelihood of undetectable minimal residual disease and progression-free...
May 07, 2025 04:26 ET | Source: Janssen Cilag International NV

European Commission approves TREMFYA® (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease

TREMFYA® (guselkumab) induction therapy administered either intravenously (GALAXI 2 and 3) or subcutaneously (GRAVITI) achieved the co-primary endpoints of clinical remissiona and endoscopic responseb...
April 25, 2025 03:00 ET | Source: Janssen Cilag International NV

TREMFYA® (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease

The firsta approved fully-human, dual-acting interleukin-23 (IL-23) inhibitor in moderately to severely active ulcerative colitis,1,2,3,4,5 guselkumab showed statistically higher rates of endoscopic...
March 28, 2025 07:20 ET | Source: Janssen Cilag International NV

TREMFYA® (guselkumab) receives positive CHMP opinion for treatment of patients with moderately to severely active Crohn’s Disease

Recommendation based on the findings from the Phase 3 studies (GALAXI programme and GRAVITI) in Crohn’s disease 1,2,3 Beerse, Belgium (28 March 2025) – Johnson & Johnson today announced that the...