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U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated
First and only drug releasing system to provide extended local delivery of a cancer medication into the bladder, with 82 percent of patients achieving complete response without the need for reinduction1 Potential practice-changing treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer who have limited options before possible bladder removal
Data published in The New England Journal of Medicine demonstrate RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) is re-setting survival expectations in first-line EGFR-mutated lung cancer
Chemotherapy-free combination regimen ushers in new era for first-line treatment, with overall survival projected to exceed four years, surpassing monotherapy TKI osimertinib by more than one year
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) prevents acquired resistance versus osimertinib in first-line EGFR-mutated non-small cell lung cancer
RYBREVANT® combination extends survival and significantly reduces common EGFR and MET resistance mutations seen with osimertinib-based treatment
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) offers unmatched survival benefit in a chemotherapy-free regimen, reducing treatment resistance vs osimertinib in first-line EGFR-mutated NSCLC
Updated MARIPOSA analysis at WCLC shows combination prevents common EGFR and MET resistance, helping patients live longer Additional study results highlight strategies to reduce dermatologic reactions and simplify administration with once-monthly subcutaneous dosing
New real-world data elevating patient perspectives highlight the need for scientific advancement in maternal fetal immunology at ISUOG 2025
Patients share experiences of confusion, fear and fragmented care in managing pregnancies at risk for hemolytic disease of the fetus and newborn (HDFN) or fetal neonatal alloimmune thrombocytopenia (FNAIT) under current standard of care These patient perspectives highlight the gap that remains for treatments that address the significant unmet need in life-threatening immune-mediated conditions during pregnancy The Phase 3 AZALEA, FREESIA-1 and FREESIA-3 clinical studies of nipocalimab, an investigational FcRn blocker, are enrolling pregnant individuals at risk for severe HDFN and FNAIT
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
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
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
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