After meeting with the FDA, the makers of intravenous meloxicam plan to resubmit the treatment’s new drug application…
FDA Expands Safety Measures for Immediate Release Opioids
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…
FDA Issues Safety Warning
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…
EU Grants Marketing Authorization for Hyrimoz; Plus FDA Rejects New Drug Application for Buprenorphine Sublingual Spray
In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
IV Tramadol Promising for Postoperative Pain; FDA Denies IV Meloxicam Approval
In its first phase 3 clinical trial, intravenous tramadol has met its primary endpoint for relieving postoperative pain…
Certolizumab Pegol Receives FDA Approval for Plaque Psoriasis
On the basis of data from multiple clinical trials, the FDA has approved certolizumab pegol for treating moderate to severe plaque psoriasis…
FDA Approves Denosumab for Glucocorticoid-Induced Osteoporosis
Denosumab is now approved to treat adults with glucocorticoid-induced osteoporosis…
FDA Updates Ixekizumab Label to Include Genital Area Psoriasis
Ixekizumab is the first agent approved by the FDA for treating plaque psoriasis to include labeling for psoriasis in the genital area…
Alendronate May Provide Cardiovascular Benefits; Plus FDA Approves Subcutaneous Tocilizumab
New research has linked alendronate to reduced cardiovascular death in hip fracture patients…
Drug Safety: Fasinumab Evaluated in Clinical Trials, Plus Celecoxib May Not Pose Increased Heart Attack or Stroke Risk
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…
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