Golimumab 50mg/4mL; soln for IV infusion after dilution; preservative- and latex-free. Simponi Aria (golimumab) Injection is a colorless to light yellow solution available in packs of 1 vial. Each ...
Janssen Biotech announced new five-year data from three pivotal Phase 3 studies evaluating Simponi (golimumab) 50mg administered subcutaneously once every four weeks in the treatment of moderately to ...
Alvotech’s inflammation-targeting biosimilar AVT05 has been rejected by the U.S. Food and Drug Administration (FDA) because of issues with the company’s manufacturing facility in Reykjavik, Iceland.
The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis. Simponi works by blocking tumor necrosis ...
On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s (NYSE:JNJ) Simponi (golimumab) for children with moderately to severely active ulcerative colitis (UC) who weigh at ...
The FDA has accepted Alvotech (NASDAQ:ALVO) and Teva's (NYSE:TEVA) Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria. Review ...
HORSHAM, Pa., Sept. 27 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration ...
GUANGZHOU, China, July 16, 2025 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today ...
Johnson & Johnson JNJ announced that the FDA has granted approval to its TNF inhibitor, Simponi Aria for the treatment of children 2 years and older with active polyarticular course juvenile ...
The European Commission has approved MSD’s biologic Simponi for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis. The European Commission has approved MSD’s ...
Dr. Reddy’s Laboratories RDY and China-based Bio-Thera Solutions announced that they have entered into commercialization and license agreements for BAT2206, a proposed biosimilar of Johnson & ...
May 15 (Reuters) - The U.S. Food and Drug Administration has approved Johnson & Johnson's drug Simponi for patients with moderate to severe ulcerative colitis, an inflammatory disease affecting the ...
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