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Innovative Medicine
JANSSEN RECEIVES TWO U.S. FDA APPROVALS FOR SIMPONI ARIA® (GOLIMUMAB) FOR THE TREATMENT OF ADULTS WITH ACTIVE PSORIATIC ARTHRITIS OR ACTIVE ANKYLOSING SPONDYLITIS
SIMPONI ARIA® is the Only Fully-Human Anti-TNF-alpha Infused Therapy Now Approved for Psoriatic Arthritis, Ankylosing Spondylitis and Rheumatoid Arthritis
Janssen Submits New Drug Application to U.S. Food and Drug Administration for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1
Janssen seeks approval for investigational regimen that aims to combine efficacy, durability, and the high genetic barrier to resistance of darunavir with the renal and bone safety profile of emtricitabine/tenofovir alafenamide in a once daily pill
Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer
First Agent Submitted to Address a Critical Need in Earlier Stage Castration-Resistant Prostate Cancer at High-Risk for Metastasis
Janssen Submits Supplemental New Drug Application (sNDA) to U.S. FDA Seeking New Indication for INVOKANA® (canagliflozin) to Reduce the Risk of Major Adverse Cardiovascular Events (MACE) Based on Landmark CANVAS Program
Filing includes data on the combined risk reduction of cardiovascular death, myocardial infarction and stroke in patients with type 2 diabetes