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 Boxed Warning for Denosumab & Approves a Generic NSAID
In January, the U.S. Food & Drug Administration approved indomethacin in an oral suspension, a generic version of Indocin Oral Suspension. The agency also issued a boxed warning and updated label for denosumab, warning of the risks of severe hypocalcemia in patients with chronic kidney disease.
Pharmacokinetic Modeling & Efficacy Extrapolation: FDA Takes New Approaches to Drug Approvals
An array of new and expanded indications of therapeutics for rheumatic disease last year relied on pharmacokinetic modeling for intravenous dosing and efficacy extrapolation for pediatric populations.
Insight into the FDA Approval of Ustekinumab Biosimilar
In late October, the FDA approved the first biosimilar to ustekinumab to treat patients with psoriasis, psoriatic arthritis and other conditions. Ustekinumab-auub is expected to be available in the U.S. by 2025.
FDA Approves New Biosimilar for Adult & Pediatric Arthritis
This year, tocilizumab biosimilars have been approved to treat adult and pediatric patients with rheumatic disease, including rheumatoid arthritis, juvenile idiopathic arthritis and more, in both Europe and the U.S.
FDA Approves Canakinumab to Treat Gout Flares
Canakinumab has received FDA approval for the treatment of patients with acute gout flares.
FDA Accepts NDA for Investigational RA Agent
The FDA has accepted an investigational new drug application (NDA) for MYMD-1, an oral tumor necrosis factor-α inhibitor for patients with rheumatoid arthritis.
FDA Commissioner Charts Potential & Challenges of Emerging Technologies in Patient Care
Disparities, representativeness, algorithmic bias, the disruptive emergence of large language models and continued misinformation spread are key issues poised to transform patient care in American healthcare, FDA Commissioner Robert M. Califf, MD, said during a recent event.
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