(Reuters)—A key U.S. government trial of Gilead Sciences Inc.’s experimental coronavirus treatment may yield results as early as mid-May, according to the study’s lead investigator, after doctors clamored to enroll their patients in the study. Preliminary findings from the randomized trial of the antiviral drug remdesivir, begun in February by the National Institute of Allergy…
Sarilumab Trial Data Shows It May Only Help Critical COVID-19 Patients
(Reuters)—On April 27, Regeneron Pharmaceuticals Inc. and Sanofi SA said on Monday that their arthritis drug sarilumab (Kevzara) may only help the sickest patients with COVID-19, dampening hopes that the therapy could potentially reach a larger pool of patients with the disease. The drugmakers said they would test high doses of sarilumab only in critically…
U.S. FDA Warns Against Using Hydroxychloroquine for COVID-19
(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)—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…
Novartis to Test Efficacy of Old Malaria Drug Against COVID-19
ZURICH (Reuters)—Swiss drugmaker Novartis AG says it will test the malaria drug hydroxychloroquine (HCQ) in a randomized trial to see if the much talked about medicine is actually effective against COVID-19, the illness caused by the novel coronavirus. The company hopes to have data on its efficacy by June, a lead researcher for the trial…
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FDA Considers Tanezumab Application for Chronic OA Pain
The FDA is considering an application for subcutaneous tanezumab, a monoclonal antibody, as a treatment for moderate to severe osteoarthritis…
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Yes, the FDA Employs Rheumatologists. Here’s Their Role.
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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FDA Approves Meloxicam Injection & OTC Diclofenac Sodium Topical Gel for Pain Management
The FDA has approved two pain medications: meloxicam in an injection and over-the-counter diclofenac sodium topical gel 1%…
Data on Arthritis Drug to Treat Coronavirus Could Come within Weeks
(Reuters)—Initial data from clinical trials testing whether patients with severe coronavirus illness can be helped by a rheumatoid arthritis drug sold by Regeneron Pharmaceuticals Inc and Sanofi SA may come as early as next week, Regeneron’s chief scientific officer told Reuters. “We could be one to two weeks—at most a month or so—away from knowing…
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Tocilizumab Begins Clinical Trial for COVID-19
The FDA has authorized a phase 3 clinical trial examining the safety and efficacy of tocilizumab plus standard care in patients hospitalized with COVID-19…
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