Innovative Medicine
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U.S. FDA Approves INVOKAMET® XR (Canagliflozin / Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes
Newest INVOKANA® (canagliflozin) plus metformin treatment provides unique formulation option for first-line therapy -
Johnson & Johnson Announces World Health Organization will Review Ebola Vaccine Regimen for Emergency Use Assessment and Listing (EUAL)
Preparations also underway to initiate first-in-human study for multivalent vaccine regimen to combat Ebola, Sudan and Marburg viruses -
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Esketamine Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Major Depressive Disorder with Imminent Risk for Suicide
FDA action marks second Breakthrough Therapy Designation for intranasal esketamine, highlighting its potential as treatment for patients with major depressive disorder who are at imminent risk for suicide and for those with treatment-resistant depression -
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U.S. FDA Approves PREZISTA® (darunavir) for Use in Pregnant Women with HIV
Data shows PREZISTA® is a safe and effective treatment option in pregnant women, with no reports of mother-to-child HIV transmission among women who continued therapy through delivery -
U.S. FDA Grants Priority Review to Janssen’s New Drug Application for Chewable Mebendazole Tablets Intended to Treat Soil-Transmitted Helminthiasis
Johnson & Johnson shows ongoing commitment to London Declaration on NTDs through advancement of new chewable tablet -
SIMPONI® Receives European Commission Approval for Treatment of Polyarticular Juvenile Idiopathic Arthritis
Health Authority Approval Marks Sixth Indication for SIMPONI in Europe -
Ibrutinib (IMBRUVICA®) Granted Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA) for the Development of a Treatment for Chronic Graft-Versus-Host Disease (cGVHD)
- In current clinical practice, there are no FDA-approved treatments for this life-threatening condition - FDA designation suggests potential use of ibrutinib beyond hematologic malignancies - The FDA also granted ibrutinib orphan drug designation for cGVHD
