The Food & Drug Administration announced Jan. 26 that tixagevimab/cilgavimab (Evusheld) is no longer authorized for use in the U.S. The decision was based on new data suggesting that the treatment is unlikely to be active against the most common current SARS-CoV-2 variants.
First Biosimilar to Adalimumab (Humira) Enters the U.S. Market After Years of Legal Battles
After years of legal disputes between drug makers, adalimumab-atto (Amjevita) biosimilar to adalimumab (Humira) is now available in the U.S. to treat rheumatoid arthritis and other diseases. Adalimumab-atto is the first of several biosimilars to adalimumab expected to become available in the U.S. in 2023.
Patients on Dialysis Taking Denosumab May Be at Risk of Severe Hypocalcemia
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, such as hospitalization and death, in patients on dialysis taking denosumab.
FDA Approves Ustekinumab for Children with PsA
After examining study data from pediatric patients with both psoriasis and psoriatic arthritis (PsA), the FDA approved ustekinumab as a treatment for patients aged 6–17 years old with PsA.
Belimumab Promising for Children with Lupus Nephritis
Belimumab is now FDA approved to treat children aged 5 years and older with active lupus nephritis, providing treatment options for pediatric patients at risk of developing renal damage.
An Evidence-Based Drug Update & Guidance for Rheumatologists
ORLANDO—Despite the COVID-19 pandemic, the past two years have been exciting for rheumatology providers and patients. We’ve seen the U.S. Food & Drug Administration (FDA) approve new therapies and expand indications for established drugs. At the 2022 ACR Education Exchange, Jeffrey Curtis, MD, MS, MPH, Marguerite Jones Harbert-Gene Ball Endowed professor of medicine, Division of…
FDA Approves Riabni, a Rituxumab Biosimilar, to Treat Patients with RA
Based on findings from a double-blind, placebo-controlled study evaluating its efficacy and safety, rituximab-arrx has received FDA approval for the treatment of patients with rheumatoid arthritis.
FDA Approves Risankizumab-rzaa for PsA
Two recent trials demonstrated the safety and efficacy of risankizumab-rzaa for the treatment of adults with active psoriatic arthritis.
FDA Approves Secukinumab for Children with Enthesitis-Related Arthritis & PsA
The FDA has approved the use of secukinumab for pediatric patients with enthesitis-related arthritis and psoriatic arthritis, after research showed a longer time to disease flare than placebo.
FDA Authorizes New Long-Acting, Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals
On Dec. 8, the U.S. Food & Drug Administration (FDA) issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). The product…
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