The FDA has approved the use of sublingual sufentanil (Dsuvia) to treat acute pain in adults in a medically supervised setting…
5-Year Data on Secukinumab in AS; Oliceridine Not Recommended for FDA Approval
In a long-term study, secukinumab proved safe and effective for treating ankylosing spondylitis…
FDA Approves Subcutaneous Tocilizumab for Ages 2–17
The FDA has approved subcutaneous tocilizumab for treating active systemic juvenile idiopathic arthritis in pediatric patients as young as 2 years old…
FDA Rejects Novartis Bid to Repurpose Inflammation Drug for Heart Attacks
ZURICH (Reuters)—The U.S. Food and Drug Administration (FDA) has rejected Novartis’s bid to repurpose a drug now approved for rare inflammatory diseases to be used in a group of heart attack survivors, according to the Swiss drugmaker. The company received an FDA letter turning down its bid to make canakinumab a targeted therapy for those…
Revised Application Expected for IV Meloxicam; Plus EU Approves Tildrakizumab
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…
- « Previous Page
- 1
- …
- 6
- 7
- 8
- 9
- 10
- …
- 28
- Next Page »