Health Canada has approved Erelzi, which is biosimilar to Enbrel (etanercept), for treating psoriatic arthritis in adults…
FDA Advisory Committee Votes in Favor of Romosozumab Approval
An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.
FDA Update: Priority Review for Non-Opioid Treatment & New Warning for Fluoroquinolones
The FDA has granted priority review to a non-opioid, postoperative pain treatment, HTX-011…
FDA Approves Rituximab Biosimilar; Plus New Safety Data for Filgotinib in RA Patients
The FDA has approved Truxima (rituximab-abbs), which is biosimilar to Rituxan (rituximab), for treating adults with CD20-positive, B-cell non-Hodgkin’s lymphoma…
FDA Update: Topical Plaque Psoriasis Treatment Approved; Dupilumab Will Receive FDA Priority Review
The FDA has approved halobetasol propionate lotion as a topical treatment for plaque psoriasis…
Rituximab Receives Label Update for ANCA-Associated Vasculitis
The FDA has approved an update for rituximab’s label, which will include safety and efficacy information for treating ANCA-associated vasculitis…
FDA Approves Opioid Treatment
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…
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