- Home
- Media Center
- Press releases
- Innovative Medicine
Innovative Medicine
U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma
Bispecific antibody targeting GPRC5D receptor showed an overall response rate of more than 70 percent with durable responses, including in patients previously treated with a bispecific antibody or CAR-T cell therapy
Janssen Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy EDURANT®
Parallel application also submitted to European Medicines Agency If approved, EDURANT® (rilpivirine) in combination with other antiretroviral therapies would offer a new HIV-1 treatment option for younger children
Johnson & Johnson Launches Exchange Offer for Separation of Kenvue Inc.
Separation enhances Company focus on Pharmaceutical and MedTech Research & Development to deliver innovative and differentiated health outcomes Johnson & Johnson shareholders can exchange all, some or none of their shares of Johnson & Johnson common stock for shares of Kenvue Provides Johnson & Johnson shareholders with option for a tax-free exchange for U.S. Federal income tax purposes
Janssen Receives Positive CHMP Opinions for Novel Bispecific Antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Talquetamab is the first therapy targeting GPRC5D to receive a positive CHMP Opinion Teclistamab, the first BCMA-targeting bispecific antibody to be approved in Europe, receives positive CHMP Opinion for reduced, biweekly dosing schedule
Treatment with RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Resulted in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer
First Phase 3 study to demonstrate clinically meaningful results versus standard of care in a newly diagnosed exon 20 population, a patient population with high unmet medical need
Janssen Announces Positive Topline Results for JNJ-2113 - a Novel, First and Only Oral IL-23 Receptor Antagonist Peptide in Development for Moderate-to-Severe Plaque Psoriasis
A greater proportion of patients achieved 100 percent improvement in skin clearance at the highest dose level tested compared to placebo, at week 16 Phase 3 clinical development in moderate-to-severe plaque psoriasis is planned
New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
92 percent of pregnancies treated with nipocalimab resulted in a live birth, with 54 percent delivering at or after 32 weeks without intrauterine transfusions1
Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking Approval of Single Tablet Combination Therapy (STCT) of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
This is the first and only single tablet combination therapy to be submitted for review in Europe for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guideline-recommended treatment pathways
Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival (PFS) CARTITUDE-4 is the first randomized Phase 3 study investigating the efficacy of a cell therapy as early as after first relapse in multiple myeloma