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Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
Johnson & Johnson intends to distribute vaccine to the U.S. government immediately following authorization, and expects to supply 100 million doses to the U.S. in the first half of 2021
Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV
CABENUVA offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression
New Data Demonstrate Long-Term Benefit of IMBRUVICA® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukemia
IMBRUVICA® pooled clinical trial analyses presented at ASH demonstrate sustained efficacy and safety in patients with historically poor outcomes Data from real-world evidence studies featured as oral presentations highlight the benefit of IMBRUVICA®-based therapies in the first-line setting
Janssen Presents First Data from the Phase 1 Study of the GPRC5DxCD3 Bispecific Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma
Data presented at ASH 2020 for first-in-class talquetamab support recommended Phase 2 dose with subcutaneous formulation
Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukemia
New data from the double-blind, placebo-controlled, randomized phase of the Phase 2 CAPTIVATE study presented at ASH 2020 showed that 95 percent of patients with undetectable minimal residual disease randomized to discontinue active treatment after twelve cycles of treatment with IMBRUVICA® plus venetoclax were disease-free and alive, supporting a fixed duration treatment approach
Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Expanded Access Program Established for Patients in the U.S. Who May Benefit from Investigational Therapy While Application is Under Review
Janssen Acquires Rights to Novel Gene Therapy, Pioneering Treatment Solutions for Late-Stage Age-Related Macular Degeneration
Acquisition significantly expands Janssen’s eye disease portfolio and strengthens its gene therapy capabilities Late-stage AMD affects millions of people with no effective treatments currently available
Late-Breaking 12-Month Data of Investigational RPGR Gene Therapy Shows Statistically Significant and Continued Vision Improvement in Patients with X-Linked Retinitis Pigmentosa
One-year findings support advancement into Phase 3 and include significant functional vision improvements observed in the time taken to walk through a vision-guided mobility maze at nine months