Tag Archives: approves

FDA Approves Zolgensma (onasemnogene abeparvovec-xioi) Gene Therapy to Treat Pediatric Patients with Spinal Muscular Atrophy

FDA Approves Zolgensma (onasemnogene abeparvovec-xioi) Gene Therapy to Treat Pediatric Patients with Spinal Muscular Atrophy Print this page May 24, 2019 — The U.S. Food and Drug Administration today 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… Read More »

FDA Approves Piqray (alpelisib) as First PI3K Inhibitor for Breast Cancer

FDA Approves Piqray (alpelisib) as First PI3K Inhibitor for Breast Cancer Print this page May 24, 2019 — Today, the U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2… Read More »

FDA Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel (etanercept)

News New Drugs FDA Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel (etanercept) Print this page April 26, 2019 The FDA has approved Eticovo (etanercept-ykro), a biosimilar to U.S.-licensed Enbrel (etanercept). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product,… Read More »