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Articles tagged with "U.S. Food and Drug Administration (FDA)"

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…

FDA Approves Tremfya (Guselkumab) for Adult Patients with Psoriatic Arthritis

Natasha Yetman  |  July 15, 2020

HORSHAM, PA—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.1,2 Tremfya is the first treatment approved for active PsA that selectively inhibits interleukin (IL)…

FDA Approves Canakinumab for Adult-Onset Still’s Disease

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

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

Michele B. Kaufman, PharmD, BCGP  |  June 8, 2020

The FDA has approved a 25 mg/mL dose of an oral solution of celecoxib to treat adults with acute migraine…

2 Pediatric Indications Sought for Golimumab

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

The FDA is reviewing supplemental Biologics License Applications for golimumab to treat polyarticular JIA and juvenile PsA…

Baricitinib Studied as Possible COVID-19 Treatment; Plus Ranitidine Removed from U.S. Market

Michele B. Kaufman, PharmD, BCGP  |  May 11, 2020

Baricitinib, an oral JAK1/JAK2 inhibitor approved to treat RA in adults, is being investigated as a possible treatment for hospitalized patients with COVID-19…

U.S. FDA Warns Against Using Hydroxychloroquine for COVID-19

Reuters Staff  |  April 27, 2020

(Reuters)—On April, the U.S. Food and Drug Administration (FDA) cautioned against the use of malaria drug hydroxychloroquine (HCQ) in COVID-19 patients even as President Donald Trump, who has touted it as a “game changer,” advocated for an additional review. The drug, first approved in 1955, provided no benefit and potentially higher risk of death for…

FDA Cautions Slower Drug Review Activity Due to Staff Reallocation for COVID-19

Reuters Staff  |  April 21, 2020

(Reuters)—On April 16, the U.S. Food & Drug Administration (FDA) cautioned that with a lot of its staff allocated to the coronavirus crisis, it may not be able to sustain its current level of timely reviews and approvals of marketing applications. FDA says it was working to ensure that the drug programs continue to see…

FDA Considers Tanezumab Application for Chronic OA Pain

Michele B. Kaufman, PharmD, BCGP  |  April 20, 2020

The FDA is considering an application for subcutaneous tanezumab, a monoclonal antibody, as a treatment for moderate to severe osteoarthritis…

Yes, the FDA Employs Rheumatologists. Here’s Their Role.

Renée Bacher  |  April 15, 2020

Ever wonder what role physician regulators—rheumatologists, in particular—perform at the U.S. Food & Drug Administration (FDA)? “I am not sure that many practicing rheumatologists know there are clinicians who work for the FDA,” says rheumatologist Nadia Habal, MD, a medical officer in the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA. “It would…

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