On Feb. 3, the U.S. Food & Drug Administration (FDA) revised its Letters of Authorization for two emergency use authorizations (EUAs), Paxlovid and Lagevrio, to remove the requirement for positive test results to prescribe these drugs. The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. The FDA recognizes…
FDA Approves Abaloparatide to Treat Men with Osteoporosis & a High Risk of Fracture
In late December, the FDA approved subcutaneous abaloparatide for the treatment of men with osteoporosis at a high risk of fracture. This approval is based on a placebo-controlled study that showed abaloparatide led to significant increases in bone mineral density of the lumbar spine, total hip and femoral neck. Abaloparatide was approved in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
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.
FDA Officials Speak Out: New Approvals & Safety Concerns Discussed
PHILADELPHIA—Officials from the U.S. Food & Drug Administration discussed recent drug approvals and drug safety issues at ACR Convergence in November in a session that captured the flurry of activity in the rheumatology sphere at the agency over the past year. Sabiha Khan, MD, clinical reviewer in the Division of Rheumatology and Transplant Medicine at…
Mitigating Drug Shortages: FDA Officials Say Communication Is Crucial
PHILADELPHIA—The most vital component of avoiding drug shortages is early communication, officials from the U.S. Food & Drug Administration (FDA) said in a session at ACR Convergence 2022 in November. “Early notification is key in order to prevent and mitigate shortages,” said Hyun Son, PharmD, a member of the Drug Shortage Staff with the FDA…
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.
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.
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 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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