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Innovative Medicine
U.S. FDA Approves Vermox™ Chewable (Mebendazole) For Treatment of Children and Adults With Roundworm and Whipworm Infections
New tablet formulation provides alternative treatment for millions of children around the world infected by intestinal worms
Ibrutinib (IMBRUVICA®) Supplemental New Drug Application Submitted to the U.S. Food and Drug Administration (FDA) for Marginal Zone Lymphoma (MZL)
Latest submission seeks marketing approval for fifth unique indication. No therapies currently approved for the treatment of patients with marginal zone lymphoma, a rare and incurable disease
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
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
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