With the approval of its Board of Directors, the ACR sent a letter to President Biden and newly minted Secretary of Health & Human Services Xavier Becerra, strongly supporting Janet Woodcock, MD, to be nominated as the FDA’s permanent commissioner. The ACR also congratulated Secretary Becerra upon his confirmation.
FDA Approves New Rituximab Biosimilar & Anakinra to Treat a Rare Disease
The FDA has approved anakinra to treat a rare autoinflammatory disease, deficiency of interleukin 1 receptor antagonist. The administration also approved a new rituximab biosimilar, Riabni, for multiple indications.
FDA Provides 2020 Rheumatology Drug Update
Three FDA representatives discuss new drug indications, safety precautions and label changes, & an emergency program to rapidly evaluate existing immunomodulating therapies for use in COVID-19 patients.
Emergency Use Approved for Baricitinib with Remdesivir Combination Therapy for SARS-CoV-2
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 Golimumab for Patients with pJIA & Psoriatic Arthritis
The FDA has approved golimumab for the treatment of pediatric patients with active polyarticular juvenile idiopathic arthritis or active psoriatic arthritis…
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.
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