The FDA placed a partial clinical hold on three of Zentalis Pharmaceuticals’ cancer treatment studies following two patient deaths.
Tag Archive for: GlaxoSmithKline
Britain’s AstraZeneca said it will pay $425 million to settle lawsuits in the United States that claimed its heartburn drugs Nexium and Prilosec caused chronic kidney disease.
Following a regulatory victory for Jemperli in endometrial cancer last month, GSK continues its oncology winning streak with an FDA approval for momelotinib in myelofibrosis with anemia.
This week, GSK is expecting a verdict for its myelofibrosis candidate momelotinib and Alnylam will make the case for patisiran in cardiomyopathy of ATTR amyloidosis.
Its British parent company GSK, which has been in Nigeria since 1971, said in 2018 that it would cut back its operations in Africa and adopt a distributor-led model instead of marketing medicines in 29 sub-Saharan African markets.
The FDA has approved Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient or microsatellite instability-high.
The Medicines and Healthcare products Regulatory Agency (MHRA) authorized GSK’s shot, called Arexvy, for active immunization to prevent lower respiratory tract disease caused by RSV in adults 60 years and older.
The U.S. Food and Drug Administration’s staff reviewers said on Tuesday the safety data for Pfizer Inc.’s experimental respiratory syncytial virus (RSV) vaccine in pregnant women was “generally favorable”.
The U.S. Food and Drug Administration has approved GSK Plc’s respiratory syncytial virus (RSV) vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people.