Based on research showing improved signs and symptoms of systemic sclerosis in patients taking cilnidipine vs. placebo, the FDA granted orphan drug designation for the agent.
Nipocalimab Receives Breakthrough Therapy Status for Sjögren’s Disease
Nipocalimab, an investigational monoclonal antibody that blocks FcRn and reduces levels of circulating immunoglobulin G (IgG) antibodies, has received the FDA’s breakthrough therapy designation for the treatment of Sjögren’s disease.
FDA Approves Suzetrigine (VX-548), a Non-Opioid Analgesic
Based on research in post-surgery patients, the FDA approved suzetrigine, a non-opioid analgesic, for the treatment moderate to severe, acute pain in adults.
mRNA CAR T Cell Therapy Receives FDA’s Rare Pediatric Designation to Treat Juvenile Dermatomyositis
FDA has granted Descartes-08, an mRNA chimeric antigen receptor T cell therapy, a rare pediatric disease designation for the treatment of juvenile dermatomyositis.
FDA Accepts New Drug Application for Suzetrigine, a Non-Opioid Analgesic
The FDA accepted a new drug application for suzetrigine, a non-opioid analgesic, based on the results from clinical trials in patients with neuropathy and those post-surgery.
FDA Approves 2 Upadacitinib Formulations for Children with pJIA & PsA
Upadacitinib, as a tablet and oral solution, is now FDA approved to treat children age 2 years and older with active polyarticular juvenile idiopathic arthritis or psoriatic arthritis.
FDA Updates Safety & Efficacy Information for Voclosporin
The FDA’s latest label change for voclosporin adds data demonstrating its safety and efficacy, as well as a sustained renal response, in patients with lupus nephritis through three years of treatment.
FDA Approves Tocilizumab Biosimilar; Plus New Lupus Drug in Early Trials
The FDA has approved tocilizumab-aazg (Tyenne), the first tocilizumab biosimilar, for treating rheumatic diseases, as well as the new drug application for CB-101, a chimeric antigen receptor T cell therapy, for treating lupus nephritis and extra-renal lupus.
New Indications Possible for Bimekizumab-bkzx
The FDA has accepted applications for three new indications for bimekizumab-bkzx, a humanized interleukin (IL) 17A and IL-17F antagonist: psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.
FDA Issues Updated Prescribing Information for Opioids & Over-the-Counter Naloxone
New prescribing guidance has been issued by the FDA for immediate-release and extended-release/long-acting opioids for pain management. The agency also announced multiple label updates, which include changes to the Boxed Warnings.
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