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Johnson & Johnson Announces Submission of European Marketing Authorisation Applications for Janssen’s Investigational Ebola Vaccine Regimen
Data from multiple preclinical, Phase 1, 2 and 3 studies support applications, which have been granted Accelerated Assessment by European Medicines Agency
Johnson & Johnson Announces Donation of up to 500,000 Regimens of Janssen’s Investigational Ebola Vaccine to Support Outbreak Response in Democratic Republic of the Congo (DRC)
The government of the DRC supports use of Janssen’s vaccine regimen as part of expanded public health response to country’s Ebola outbreak – the second-worst on record
New OPSUMIT® (macitentan) Data Show Initial Combination Therapy with Tadalafil Improved Hemodynamic Clinical and Functional Parameters in Patients with Pulmonary Arterial Hypertension
OPSUMIT, as part of a combination regimen, reduced the primary endpoint of mean pulmonary vascular resistance by 47% at week 16 compared with baseline
Janssen Announces U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative
In the Phase 3 pivotal trial, more than 40 percent of patients receiving STELARA subcutaneous (SC) injections every 8 weeks were in clinical remission at one year and not taking corticosteroids STELARA is the first and only approved treatment for ulcerative colitis to demonstrate improvement of the colon as measured by a novel histologic-endoscopic mucosal improvement endpoint
Janssen Receives Positive CHMP Opinion for Spravato® (Esketamine) Nasal Spray for Adults with Treatment-Resistant Major Depressive Disorder
If approved by the European Commission, esketamine nasal spray will offer the first new mechanism of action in 30 years to treat major depressive disorder (MDD) In the phase III clinical development programme with flexible dosing, esketamine nasal spray and a newly initiated oral antidepressant achieved superior improvement in depression symptoms, and sustained improvement in their symptoms over time compared to adults who received a placebo and an oral antidepressant1,2
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant prostate cancer and BRCA1/2 DNA repair gene defects
U.S. FDA Approves INVOKANA® (canagliflozin) to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes (T2D) and DKD
Learn about the FDA approval of Invokana, a breakthrough in treating diabetic kidney disease and reducing heart failure risk in patients with type 2 diabetes.
Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma
Approval represents first and only FDA-approved biologic indicated for newly diagnosed patients who are eligible for a stem cell transplant Marks the seventh approved indication for DARZALEX®
XARELTO® (rivaroxaban) Reduces Recurrent Blood Clots and Total Medical Costs in Morbidly Obese Patients
New real-world study of patients with venous thromboembolism (VTE) and morbid obesity shows safety and effectiveness of XARELTO® were similar to warfarin, with significantly less healthcare resource utilization (HRU) and total medical costs