Innovative Medicine
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DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible
Findings from first-ever quadruplet therapy study with subcutaneous DARZALEX FASPRO® showed 60 percent reduction in risk of disease progression or death New regimen solidifies DARZALEX FASPRO® as a foundational frontline therapy in multiple myeloma with potential to significantly delay disease progression -
Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
Phase 4 SPRAVATO® monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at least 4 weeks Monotherapy submission builds on more than a decade of research, 31 clinical trials and more than five years of real-world use that reinforce the safety and efficacy of SPRAVATO® -
Johnson & Johnson strengthens pipeline to lead in atopic dermatitis with acquisition of Yellow Jersey Therapeutics
NM26 is a Phase 2-ready, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis (AD) The Company is leveraging a multi-pathway approach to transform treatment in atopic dermatitis and other immune-mediated diseases -
Johnson & Johnson Receives Approval from U.S. FDA and European Commission for SIRTURO® (bedaquiline)
Approvals supported by Phase 3 STREAM Stage 2 study results confirming favorable treatment outcomes compared to injectable-containing regimens Approvals of SIRTURO® follow accelerated approval by U.S. FDA in December 2012 and conditional approval by the EMA in March 2014 -
CARVYKTI® (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement in overall survival in landmark CARTITUDE-4 study
CARVYKTI ® is the first and only BCMA-targeted CAR-T cell therapy approved by the U.S. FDA for the treatment of patients with multiple myeloma who have had at least one prior line of therapy -
Johnson & Johnson completes acquisition of Proteologix, Inc.
Acquisition includes two pre-clinical bispecific antibodies targeting proven disease pathways, offering the potential to transform the treatment paradigm for patients living with atopic dermatitis and other immune-mediated diseases -
Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer
Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five-minute administration of subcutaneous amivantamab Longer overall survival, progression-free survival and duration of response also observed with subcutaneous amivantamab -
TALVEY® (talquetamab-tgvs) demonstrates highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma
24-month overall survival rate of 67 percent achieved with TALVEY® 0.8 mg/kg biweekly dosing in the Phase 1/2 MonumenTAL-1 study -
Findings from landmark RESONATE-2 study confirm sustained survival benefit of IMBRUVICA® (ibrutinib) for first-line chronic lymphocytic leukaemia treatment with up to 10 years follow-up
RESONATE-2 data presented at the 2024 European Hematology Association (EHA) Congress provide longest-term outcomes and safety data ever reported for a monotherapy BTK inhibitor, with a median progression-free survival of 8.9 years1 Additional findings from pooled analysis of three Phase 3 studies showed treatment with ibrutinib has the potential to achieve comparable overall survival to the general European population2