Upadacitinib will soon be available to treat patients with moderate to severe rheumatoid arthritis in Canada and the E.U…
EU Approves Remsima SC, a Biosimilar to Infliximab
Subcutaneous CT-P13 (Remsima SC), biosimilar to infliximab, will soon be available in the E.U. to treat adults with rheumatoid arthritis…
FDA Approves Amgen’s Infliximab Biosimilar Treatment
(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…
Rituximab-abbs Available in the U.S.; Plus Upadacitinib in Phase 3 Trials for PsA
Rituximab-abbs, which is biosimilar to rituximab, is now available in the U.S. to treat specific cancers…
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…
Clinical Insights into Gout Management: Rheumatology Drugs at a Glance Pt. 4
Three clinical experts on gout offer their insights into common management errors, clinical pearls, new safety data from the FDA and the role of biologic therapies in the management of gout.
FDA Approves the Biosimilar Hadlima (Adalimumab-bwwd)
Hadlima (adalimumab-bwwd), which is biosimilar to adalimumab, is now FDA approved to treat multiple autoimmune diseases…
Amgen Wins U.S. Patent Battle on Arthritis Drug Enbrel
(Reuters)—A U.S. judge on Friday upheld two patents relating to Amgen Inc,’s blockbuster rheumatoid arthritis drug Enbrel (etanercept), denying a challenge by Novartis AG, which is seeking to launch a biosimilar version. The decision was a relief to investors concerned about a competitive threat to Enbrel, which had U.S. sales of $4.8 billion last year….
Samsung Bioepis Humira Biosimilar Wins FDA Approval
(Reuters)—The U.S. Food and Drug Administration approved Samsung Bioepis Co. Ltd.’s biosimilar to AbbVie Inc.’s blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday. The drug, Hadlima, was developed by South Korea’s Samsung Bioepis and comes with a boxed warning, the FDA’s harshest. The agency flagged increased risk of serious infections, including tuberculosis…
Subcutaneous CT-P13 Injection Evaluated for Safety & Efficacy of in RA Patients
Results from a one-year study suggest subcutaneous CT-P13, which is biosimilar to infliximab, is as safe and effective for RA patients as intravenous (IV) CT-P13 and IV infliximab…
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