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Articles tagged with "FDA"

FDA Approves New Rituximab Biosimilar & Anakinra to Treat a Rare Disease

Michele B. Kaufman, PharmD, BCGP  |  February 2, 2021

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

Susan Bernstein  |  December 17, 2020

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

Michele B. Kaufman, PharmD, BCGP  |  December 3, 2020

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

Michele B. Kaufman, PharmD, BCGP  |  October 28, 2020

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

Michele B. Kaufman, PharmD, BCGP  |  October 9, 2020

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

Michele B. Kaufman, PharmD, BCGP  |  October 7, 2020

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

Michele B. Kaufman, PharmD, BCGP  |  September 30, 2020

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

Michele B. Kaufman, PharmD, BCGP  |  September 14, 2020

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

Michele B. Kaufman, PharmD, BCGP  |  August 6, 2020

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

Michele B. Kaufman, PharmD, BCGP  |  August 5, 2020

In June, the FDA approved secukinumab to treat non-radiographic axial spondyloarthritis after data from a clinical trial demonstrated its efficacy…

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