Tag Archives: Approves

FDA Approves Ruzurgi (amifampridine) for Children with Lambert-Eaton Myasthenic Syndrome

FDA Approves Ruzurgi (amifampridine) for Children with Lambert-Eaton Myasthenic Syndrome Print this page May 06, 2019 — The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years to less than 17 years of age. This is the first FDA approval of a… 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 »

FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC

Print this page KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not… Read More »