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

FDA Greenlights Osteoporosis Drug for Postmenopausal Women

Saumya Joseph  |  April 11, 2019

(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…

FDA Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare

Michele B. Kaufman, PharmD, BCGP  |  March 12, 2019

The FDA has issued a boxed warning for febuxostat after a safety study found an increased risk of heart-related and other death in RA patients…

Safety Risk with Higher Dose Tofacitnib

Michele B. Kaufman, PharmD, BCGP  |  March 6, 2019

According to the FDA, an ongoing safety trial found higher dose tofacitinib increased the risks of pulmonary embolism and death in RA patients…

Tainted Research Repeatedly Re-Used to Assess Drug Effectiveness

Gene Emery  |  March 5, 2019

(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  |  March 5, 2019

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

Michele B. Kaufman, PharmD, BCGP  |  February 28, 2019

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,…

Canada Approves Erelzi for PsA; Plus FDA Moves to Increase Access to Naloxone

Michele B. Kaufman, PharmD, BCGP  |  February 4, 2019

Health Canada has approved Erelzi, which is biosimilar to Enbrel (etanercept), for treating psoriatic arthritis in adults…

FDA Advisory Committee Votes in Favor of Romosozumab Approval

Michele B. Kaufman, PharmD, BCGP  |  January 30, 2019

An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.

FDA Update: Priority Review for Non-Opioid Treatment & New Warning for Fluoroquinolones

Michele B. Kaufman, PharmD, BCGP  |  January 23, 2019

The FDA has granted priority review to a non-opioid, postoperative pain treatment, HTX-011…

FDA Approves Rituximab Biosimilar; Plus New Safety Data for Filgotinib in RA Patients

Michele B. Kaufman, PharmD, BCGP  |  January 7, 2019

The FDA has approved Truxima (rituximab-abbs), which is biosimilar to Rituxan (rituximab), for treating adults with CD20-positive, B-cell non-Hodgkin’s lymphoma…

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