Global Reach Health

November 28, 2018

Firdapse Approved to Treat Rare Autoimmune Disorder

November 28, 2018 – The U.S. FDA has approved Firdapse® (amifampridine), manufactured by Catalyst Pharmaceuticals, Inc., to treat adult patients who have Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder. Firdapse is the first FDA-approved treatment for LEMS.
November 26, 2018

New Dosage Form of Actemra Approved

November 26, 2018 – The U.S. FDA has approved the ACTPenTM 162mg/0.9mL prefilled auto-injector, a new dosage form of Genentech's Actemra® (tocilizumab). It is indicated for the treatment of certain patients who have rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), or systemic juvenile idiopathic arthritis (SJIA).
November 16, 2018

Temixys Approved to Treat HIV

November 16, 2018 – The U.S. FDA has approved TemixysTM (300mg lamivudine/300mg tenofovir disoproxil fumarate), manufactured by Celltrion, for use in combination with other antiretroviral agents to treat HIV-1 infection in adults and pediatric patients who weigh at least 35kg (77 pounds).