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Zolgensma (onasemnogene abeparvovec-xioi), innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality
26 May 2019
The U.S. Food and Drug Administration has approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality. “Today’s…
FDA approves Fragmin (dalteparin sodium) first anticoagulant for pediatric patients to treat potentially life-threatening blood clots
18 May 2019
The U.S. Food and Drug Administration has approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include deep vein thrombosis (blood clot in the deep veins…
Dengvaxia, the first vaccine approved by FDA for the prevention of dengue disease caused by all dengue virus serotypes
7 May 2019
The U.S. Food and Drug Administration has announced the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in…
FDA approves Benlysta (belimumab) first treatment for pediatric patients with lupus
27 April 2019
The U.S. Food and Drug Administration has approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) – often referred to as simply “lupus” – a serious chronic disease that causes inflammation and damage to various body tissues and…
Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analyses of Opdivo (nivolumab) in Previously-Treated Non-Small Cell Lung Cancer Patients
17 April 2019
Bristol-Myers Squibb has announced results from pooled analyses of survival data from four studies in patients with previously-treated advanced non-small cell lung cancer (NSCLC) who were treated with Opdivo. In the pooled analysis of the four studies, 14% of all Opdivo-treated patients were alive…
Dovato (dolutegravir and lamivudine), a new complete regimen for HIV-infected patients who have never received antiretroviral treatment
9 April 2019
The U.S. Food and Drug Administration has approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with…
Mayzent (siponimod) tablets approved by FDA to treat adults with relapsing forms of multiple sclerosis (MS)
3 April 2019
The U.S. Food and Drug Administration has approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. “Multiple sclerosis can have a profound…
Zynteglo, New gene therapy to treat rare inherited blood condition
2 April 2019
EMA has recommended granting a marketing authorisation in the European Union for a genetically modified product for beta-thalassaemia, a rare inherited blood condition that causes severe anaemia. Zynteglo is intended for adult and adolescent patients 12 years and older who need regular blood…
Merck has announced the FDA approval of its Mavenclad (cladribine) tablets in various forms of multiple sclerosis (MS).
1 April 2019
The U.S. Food and Drug Administration has approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease. Mavenclad is not recommended for MS patients with clinically isolated…