Genentech presented new data on Enspryng (satralizumab-mwge), which was approved by the U.S. Food and Drug Administration in mid-August 2020 as a subcutaneous treatment for adults with anti-aquaporin-4 antibody positive neuromyelitis optica spectrum.
The U.S. Food and Drug Administration approved a new indication for GlaxoSmithKline plc and Innoviva Inc.’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to the product’s current license for use in patients with chronic obstructive pulmonary disease (COPD).
The U.S. Food and Drug Administration granted an emergency use authorization for a Covid-19 test from Alphabet Inc. unit Verily Life Sciences.
The U.S. Food and Drug Administration approved Athena Bioscience LLC’s Qdolo (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
A therapy jointly developed by Switzerland’s Roche Holding AG and Cambridge, Mass.-based Blueprint Medicines Corp. was approved by the U.S. health regulator for the treatment of patients with a type of non-small cell lung cancer (NSCLC).
The U.S. Food and Drug Administration approved two additional doses of Eli Lilly and Company’s Trulicity (dulaglutide).
The U.S. Food and Drug Administration approved Switzerland-based pharmaceutical company Roche’s HIV-1/HIV-2 qualitative test for use on the fully automated Cobas 6800/8800 Systems.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
AstraZeneca Plc’s Imfinzi was approved in the European Union to treat an aggressive form of lung cancer in previously untreated adult patients.
Former U.S. Food and Drug Administration Commissioner Scott Gottlieb criticized current FDA Commissioner Stephen Hahn’s comments to the Financial Times that he would potentially fast-track a Covid-19 vaccine before clinical trials are done if it was “appropriate.”