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

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

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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)…

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

Reuters Staff  |  

(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  |  

(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…

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

Renée Bacher  |  

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…