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First generic version of Sabril (vigabatrin) approved by FDA for the treatment of complex partial seizures
25 January 2019
The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded…
Ultomiris (ravulizumab), approved by FDA for the treatment of paroxysmal nocturnal hemoglobinuria (PNH)
25 January 2019
The U.S. Food and Drug Administration has approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. “The approval of Ultomiris will change the way that patients with PNH are treated,”…
European Commission Approves Merck’s DELSTRIGO (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen for the Treatment of HIV-1 in Appropriate Patients
11 January 2019
Delstrigo is an antiviral medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Delstrigo contains the active substances doravirine, lamivudine and tenofovir disoproxil. The medicine is not suitable…
FDA approves Elzonris (tagraxofusp-erzs), first treatment for rare blood disease
7 January 2019
The U.S. Food and Drug Administration has approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older. “Prior to today’s approval, there had been no FDA approved therapies for…