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 ...
(RTTNews) - Shares of Alvotech (ALVO), a biotech company that manufactures biosimilar medicines, were trading 22.88% lower at $5.90 in pre-market trading on Monday, following disappointing regulatory ...
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 ...
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 ...
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 ...
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.
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 ...
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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