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

FDA Approves Drug for Lambert-Eaton Myasthenic Syndrome

Reuters Staff  |  

(Reuters)—Jacobus Pharmaceutical Co Inc on Monday won U.S. approval for the first drug to treat children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder. The drug, Ruzurgi (amifampridine), was approved for use in patients ages 6–17, the according to the U.S. Food and Drug Administration (FDA). Lambert-Eaton myasthenic syndrome (LEMS), which affects about three people…

FDA Greenlights Osteoporosis Drug for Postmenopausal Women

Saumya Joseph  |  

(Reuters)—The U.S. Food and Drug Administration says it has approved Amgen’s osteoporosis treatment for postmenopausal women who are at high risk of fracture. Evenity (romosozumab-aqqg), developed jointly with Belgium-based UCB SA, helps reduce the risk of fracture by increasing bone mass and mildly inhibiting the break down of bone minerals. Romosozumab-aqqg belongs to a new…

Tainted Research Repeatedly Re-Used to Assess Drug Effectiveness

Gene Emery  |  

(Reuters Health)—A new study shows how fake news—specifically, information about scientific research that may be tainted by fraud—keeps getting spread through the medical literature, misleading doctors about the safety and effectiveness of the drugs they prescribe. At issue is the failure of medical journals to flag research that’s been identified by the U.S. Food and…

U.S. FDA Chief Gottlieb Resigns

Yasmeen Abutaleb  |  

WASHINGTON (Reuters)—U.S. Food and Drug Administration (FDA) Chief Scott Gottlieb said he plans to step down in a month, calling into question how the agency will handle critical issues, such as e-cigarette use among teens and efforts to increase competition in prescription drugs. The U.S. Department of Health and Human Services (HHS), which oversees the…

Upadacitinib at the FDA

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Upadacitinib is an investigational, oral, small molecule JAK1-selective inhibitor, which recently completed phase 3 clinical trials for treating patients with moderate to severe rheumatoid arthritis (RA). In late 2018, AbbVie Inc. submitted a New Drug Application to the U.S. Food and Drug Administration, as well as a marketing authorization application to the European Medicines Agency,…