Johnson & Johnson Innovative Medicine
Pharmaceutical Companies of Johnson and Johnson
Johnson & Johnson’s DARZALEX (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers
Landmark decision by CHMP grants approval for self or caregiver administration for patients living with multiple myeloma Milestone is a testament to ten years of daratumumab experience and innovation, continuing to transform multiple myeloma care 27 March 2026 -- Beerse, Belgium -- Johnson & Johnson today announced that the Committee for Medicinal Products for Human...
European Commission approves AKEEGA (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC)
Niraparib and abiraterone acetate regimen demonstrates clinically meaningful delay in disease progression, nearly halving the risk of progression or death, with an early trend toward improved overall survival versus standard of care Approximately one in ten patients with mHSPC harbour BRCA1/2 alterations, reinforcing the need for new targeted treatment options Expanded indication for niraparib and...
Early study results from Johnson & Johnson show promising antitumor activity with combination of pasritamig and docetaxel in advanced prostate cancer
Combination demonstrates deep PSA responses and favorable safety profile with plans to advance into Phase 3 Data highlight the potential of this first-in-class next-generation T-cell engager to expand the role of immunotherapy in prostate cancer. 26 February 2026 -- New Jersey, US -- Johnson & Johnson today announced preliminary results from a Phase 1b study...
Johnson & Johnson receives CHMP positive opinion for AKEEGA (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations
AMPLITUDE is the first clinical trial to evaluate potential therapies for patients with mHSPC and known HRR gene alterations, with positive results supporting the niraparib-based combination regimen as a new standard of care for patients with BRCA mutations Results demonstrate a delay in disease progression and an early trend toward improved overall survival with the niraparib...
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 at Week 12 compared to placebo Guselkumab demonstrated statistically significant and clinically meaningful improvements in clinical remissiona and endoscopic responseb at Week 48 compared to placebo in all three studies Data...
Johnson & Johnson submits application to the European Medicines Agency for additional subcutaneous RYBREVANT▼(amivantamab) dosing regimens to treat patients with EGFR-mutated advanced non-small cell lung cancer
Application supports every-three-week (Q3W) and every-four-week (Q4W) SC amivantamab dosing regimens Subcutaneous (SC) amivantamab offers patients greater convenience with reduced administration time from hours to minutes and lower rates of IRRs and associated symptoms compared to the intravenous (IV) formulation. 6 May 2025 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson & Johnson company,...
Johnson & Johnson highlights new data, demonstrating long-term sustained disease control in adults living with generalised myasthenia gravis (gMG)
New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open label extension phase Up to 128 weeks and 180 patient years of follow-up in the open label extension phase demonstrates a safety profile consistent with the Phase 3 Vivacity-MG3 study 45%...
European Commission approves Johnson & Johnson’s subcutaneous DARZALEX (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility
Approval cements daratumumab as a foundational therapy in newly diagnosed multiple myeloma and the only anti-CD38 antibody for all patient types in this setting Phase 3 CEPHEUS study shows significant improvement in minimal residual disease (MRD)-negativity rate, progression-free survival and complete response or better versus standard of care. 7 April 2025 -- Beerse, Belgium -- Janssen-Cilag...
European Commission approves subcutaneous RYBREVANT▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Subcutaneous (SC) amivantamab offers patients greater convenience, reducing administration time from hours to minutes and with a five-fold reduction in infusion-related reactions compared to the IV formulation European Commission (EC) approval based on positive results from the Phase 3 PALOMA-3 study. 7 April 2025 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced that...
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 28 March 2025 -- Beerse, Belgium -- Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the Marketing Authorisation for TREMFYA® (guselkumab) to...
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