(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…
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…
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…
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…
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…
Sanofi Can Produce Millions of Doses of HCQ, Potential Coronavirus Drug
PARIS (Reuters)—Sanofi SA will be able to provide millions of doses of hydroxychloroquine (HCQ) for patients with the illness caused by the novel coronavirus if the old malaria drug proves successful in clinical trials, its chief executive tells Reuters on Thursday. Paul Hudson, who became CEO of the French drugmaker in September, said in an…
U.S. FDA Says HCQ & Other Malaria Drugs in Shortage as COVID-19 Drives Up Demand
April 1 (Reuters)—The U.S. Food and Drug Administration (FDA) said malaria drugs hydroxychloroquine and related chloroquine are in shortage due to a surge in demand because of the coronavirus pandemic. The drugs, which have been tried with some success to treat the illness caused by the virus, were added to the agency’s website that lists…
Sanofi, Regeneron Expand Testing of Potential Coronavirus Treatment
(Reuters)—Sanofi and Regeneron Pharmaceuticals Inc. have expanded a clinical trial of their rheumatoid arthritis drug Kevzara (sarilumab) as a coronavirus treatment to patients outside the U.S. The companies said enrolments for the mid-to-late stage trial of sarilumab, an immune-system modifying drug known as a monoclonal antibody, have now started in Italy, Spain, Germany, France, Canada…
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