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J&J Innovative Medicine
August 1, 2025
Update on U.S. regulatory review of supplemental biologics license application
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J&J Innovative Medicine
July 24, 2025
Johnson & Johnson showcases latest advancements in Alzheimer’s research at AAIC 2025
Early data from robust Autonomy Phase 2b posdinemab trial demonstrate Company’s leadership in multimodal biomarkers and early detection New findings highlight the central role of tau in disease progression, bolstering confidence in the Company’s industry-leading anti-tau portfolio Featured research session to share new findings from GNPC, the world’s largest neurodegenerative disease proteomics resource, co-founded with Gates Ventures
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Innovative Medicine
July 23, 2025
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 by 51 percent compared to active monitoring1 This milestone marks a critical advance in early intervention for multiple myeloma as the first authorised treatment, offering a new treatment paradigm for patients with high-risk smouldering disease2
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Innovative Medicine
July 23, 2025
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 transplant eligible patients with mantle cell lymphoma1 Data from the Phase 3 TRIANGLE study defines the fixed-duration ibrutinib-based regimen as a new standard of care (SOC) with significantly improved overall survival and failure-free survival versus ASCT1
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Innovative Medicine
July 21, 2025
Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque psoriasis patients with the standout combination of complete skin clearance, a favorable safety profile, and simplicity of a once daily pill
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Innovative Medicine
July 17, 2025
Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer
New Drug Application supported by results from the Phase 2b SunRISe-1 study
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