The FDA has expanded the new Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to include immediate release opioids. The program, which also includes extended release and long acting opioids, will provide education to prescribers and healthcare professionals…
The FDA is warning that patients with type 2 diabetes taking SGLT2 inhibitors may be at risk of developing a rare, serious infection, Fournier’s gangrene…
In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
In its first phase 3 clinical trial, intravenous tramadol has met its primary endpoint for relieving postoperative pain…
On the basis of data from multiple clinical trials, the FDA has approved certolizumab pegol for treating moderate to severe plaque psoriasis…
Denosumab is now approved to treat adults with glucocorticoid-induced osteoporosis…
Ixekizumab is the first agent approved by the FDA for treating plaque psoriasis to include labeling for psoriasis in the genital area…
New research has linked alendronate to reduced cardiovascular death in hip fracture patients…
After an independent review, ongoing clinical trials investigating the safety of fasinumab for treating hip or knee OA will discontinue the use of higher fasinumab doses…
(Reuters)—An experimental rheumatoid arthritis drug developed by Eli Lilly and Co. and Incyte Corp. poses serious risks of deadly blood clots at higher doses, U.S. Food and Drug Administration staff says, the latest setback to a treatment regulators declined to approve last year. New data provided by the companies in a resubmission of their marketing…