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…
FDA Staff Raises Safety Concerns Over Arthritis Drug Baricitinib
(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…
FDA to Review Abuse Deterrent Oxycodone Capsule & More
The FDA will discuss a New Drug Application for Remoxy ER during an upcoming advisory committee meeting and recently approved tildrakizumab-asmn to treat adults with plaque psoriasis…
Dermatology Patients on Corticosteroids May Not Receive Osteoporosis Screenings; Plus FDA Approves ZTLido
A recent study found that dermatology patients taking long-term steroids are not always evaluated for steroid-induced osteoporosis…
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