The U.S. Food and Drug Administration approved AstraZeneca’s top-selling treatment Tagrisso for another type of lung cancer when diagnosed at an early stage.
The U.S. Food and Drug Administration approved Takeda Pharmaceutical’s supplemental New Drug Application for Iclusig (ponatinib) for adult patients with chronic-phase chronic myeloid leukemia with resistance or intolerance to at least two prior kinase inhibitors.
The U.S. Food and Drug Administration approved GlaxoSmithKline plc’s Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-approved test.
AstraZeneca’s Brilinta (ticagrelor) was approved by the U.S. Food and Drug Administration to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack.
Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
The United States Food and Drug Administration approved Pfizer Inc.’s Xeljanz (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
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 approved Bavencio (avelumab) for maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-containing chemotherapy.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.