Approvals

FDA
Tuesday afternoon the U.S. Food and Drug Administration approved Tepezza (teprotumumab-trbw) as the first treatment for this condition.
FDA
AstraZeneca’s Imfinzi (durvalumab) and tremelimumab were granted Orphan Drug designation by the U.S. Food and Drug Administration as a possible treatment for hepatocellular carcinoma.
FDA
For patients with diabetes, the new indication could become a key for survival as there is a well-established link between cardiovascular disease and type 2 diabetes.
FDA
Investigators found that the U.S. Food and Drug Administration is approving drugs faster than ever. Unfortunately, it appears that the agency is also approving those drugs on less data and weaker evidence.
What’s New at the J.P. Morgan Life Healthcare Conference?
FDA
Emma Walmsley, chief executive officer of GlaxoSmithKline, is predicting a good year for her company, with the potential of six regulatory approvals in the United States.
The first full business week of the new year began with plenty of clinical trial news. Here’s a look.
The State of California is considering a measure to sell its own brand of generic drugs in an effort to get in on those cost-savings. California’s Gov. Gavin Newsom is expected to reveal the scheme today in his new state budget.
FDA
Late Thursday, the U.S. Food and Drug Administration approved a new therapy to treat a rare mutation in patients with gastrointestinal stromal tumors.
FDA
Merck’s checkpoint inhibitor Keytruda (pembrolizumab) continues moving toward the projections of becoming the world’s best-selling drug.
PRESS RELEASES