The FDA issued an emergency use authorization for the use of baricitinib combined with remdesivir to treat patients hospitalized with COVID-19.
FDA Warning: Avoid Use of NSAIDs after Week 20 of Pregnancy
The FDA is recommending pregnant women avoid using NSAIDs as early as week 20 of pregnancy due to the risk of kidney problems in a developing fetus.
FDA Approves Tofacitinib for Young Patients with Active Polyarticular JIA
Tofacitinib is now FDA approved to treat patients 2 years and older with active, polyarticular juvenile idiopathic arthritis.
FDA Updates Boxed Warning of Benzodiazepines, Adding Risks for Abuse & Addiction
The FDA is requiring all benzodiazepines to carry an updated boxed warning that addresses the risks of misuse, abuse and addiction associated with their use.
FDA Receives Upadacitinib Application for Ankylosing Spondylitis & Approves Tramadol Hydrochloride Oral Solution
In August, Abbvie submitted a new drug application for upadacitinib to treat ankylosing spondylitis. And in September, the FDA approved an oral solution of tramadol hydrochloride for pain.
U.S. & E.U. Differ on Filgotinib for RA
This summer, the FDA rejected a new drug application for filgotinib to treat RA in the U.S., but a European Medicines Agency committee issued a positive opinion, moving filgotinib closer to authorized use in the E.U.
Guselkumab Approved for PsA
Based on data from two clinical trials, the FDA has approved guselkumab to treat adult patients with active psoriatic arthritis…
FDA Approves Secukinumab for Non-Radiographic Axial Spondyloarthritis
In June, the FDA approved secukinumab to treat non-radiographic axial spondyloarthritis after data from a clinical trial demonstrated its efficacy…
FDA Approves Canakinumab for Adult-Onset Still’s Disease
Canakinumab, an interleukin (IL) 1 blocker, can now be prescribed to treat patients with active Still’s disease and adult-onset Still’s disease (AOSD)…
FDA Approves Celecoxib in an Oral Solution
The FDA has approved a 25 mg/mL dose of an oral solution of celecoxib to treat adults with acute migraine…
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