ATLANTA—New drug approvals, new and expanded drug indications, and important safety and other updates relevant for rheumatologists were presented by three physicians from the U.S. Food & Drug Administration (FDA) on Nov. 11 at the 2019 ACR/ARP Annual Meeting. New JAK Inhibitor Approved for RA On Aug. 16, 2019, the FDA approved upadacitinib (Rinvoq), an…
FDA advisory committees rejected the new drug application for oxycodegol, an opioid analgesic, due to a lack of data regarding it’s potential for abuse…
Last year, the FDA was busy with new biologic and other drug approvals, new and expanded drug indications, and important safety updates relevant to rheumatology…
Upadacitinib will soon be available to treat patients with moderate to severe rheumatoid arthritis in Canada and the E.U…
Gabapentinoid products will now carry warning labels about the risks of respiratory distress when combined with opioids and other nervous system and respiratory depressants…
(Reuters)—The U.S. Food and Drug Administration on Friday approved Amgen Inc.’s biosimilar copy of Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade (infliximab), according to the regulator’s website. The biosimilar, Avsola (infliximab-axxq), has the same chemical components, dosage form and strength as Remicade and would treat a range of autoimmune disorders. The label for the…
The FDA has limited the package size of some over-the-counter loperamide products to prevent its potential misuse and abuse…
(Reuters)—U.S. President Donald Trump has nominated Stephen Hahn, MD, chief medical executive of the University of Texas MD Anderson Cancer Center, to lead the U.S. Food and Drug Administration (FDA), the White House said on Friday. Dr. Hahn, a radiation oncologist who has been at MD Anderson in Houston since 2015, if confirmed would follow…
Data from two phase 3 studies were used to support the FDA’s approval of ixekizumab for adults with ankylosing spondylitis…
Hadlima (adalimumab-bwwd), which is biosimilar to adalimumab, is now FDA approved to treat multiple autoimmune diseases…