(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…
FDA Action on Loperamide Misuse; Plus Phase 1 Trials for BAT2506 Biosimilar Begin
The FDA has limited the package size of some over-the-counter loperamide products to prevent its potential misuse and abuse…
Trump Nominates MD Anderson Oncologist as U.S. FDA Commissioner
(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…
FDA Approves Ixekizumab for Treating Active Ankylosing Spondylitis
Data from two phase 3 studies were used to support the FDA’s approval of ixekizumab for adults with ankylosing spondylitis…
FDA Approves the Biosimilar Hadlima (Adalimumab-bwwd)
Hadlima (adalimumab-bwwd), which is biosimilar to adalimumab, is now FDA approved to treat multiple autoimmune diseases…
FDA Approves Upadacitinib for RA
Results from multiple phase 3 clinical trails have led to the FDA approval of upadacitinib to treat patients with moderate to severe active RA…
FDA Approves AbbVie’s New Rheumatoid Arthritis Drug
(Reuters)—The U.S. Food and Drug Administration (FDA) on Friday approved AbbVie Inc.’s new treatment for rheumatoid arthritis (RA), a win for the drugmaker seeking to widen its portfolio as its blockbuster flagship therapy Humira (adalimumab) faces competition. The drug, Rinvoq (upadacitinib), is a JAK inhibitor. It is set to compete with Pfizer Inc.’s Xeljanz (tofacitinib)…
FDA Approves Risankizumab, Adds Stronger Warning to Sleep Medications
The FDA has approved rizankixumab to treat adults with plaque psoriasis and added boxed warnings to sleep medications…
Ixekizumab Promising for Non-Radiographic Axial SpA; Plus FDA Approves Belimumab for Pediatric Lupus
Results from a Phase 3 study showed ixekizumab significantly improved the signs and symptoms of non-radiographic axial spondyloarthritis in patients…
IV Meloxicam Stalls at FDA; Plus Health Canada Approves Risankizumab for Plaque Psoriasis
In a second response letter, the FDA has cited the onset and duration of intravenous meloxicam, a non-opioid pain treatment, as concerns that it fails to meet prescriber expectations…
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