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Infliximab News
Data Suggests TNF Inhibitors Help Prevent Serious Complications in Children with Crohn's Disease
FRIDAY, Dec. 27, 2024 A specific class of anti-inflammatory drugs can help children avoid a debilitating complication of Crohn’s disease. A new study published recently in the journal Gut shows c...
FDA Approves Zymfentra (infliximab-dyyb) Subcutaneous Formulation for the Treatment of People With Inflammatory Bowel Disease
JERSEY CITY, N.J.--(BUSINESS WIRE) October 23, 2023 --Today, Celltrion USA announced that the U.S. Food and Drug Administration (FDA) has approved Zymfentra (infliximab-dyyb) for maintenance therapy...
FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade
THOUSAND OAKS, Calif., Dec. 6, 2019 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Avsola (infliximab-axxq) for all approved...
FDA Approves Ixifi (infliximab-qbtx), a Biosimilar to Remicade
December 13, 2017 – Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Ixifi (PF-06438179, infliximab-qbtx), a chimeric...
FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade
INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Renflexis (infliximab-abda), a biosimilar referencing Rem...
FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade
April 5, 2016 – The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second...
FDA Medwatch Alert: Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults
[UPDATED 11/04/2011] Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should include: p...
FDA Approves Remicade to Treat Ulcerative Colitis in Children Older than 6 Years
The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate...
FDA Medwatch Alert: Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria
including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) ISSUE: FDA notified healthcare professionals that the Boxed Warning for...
FDA Medwatch Alert: Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults
[Posted 04/14/2011] ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being...
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Ulcerative Colitis, Crohn's Disease, Ankylosing Spondylitis, Crohn's Disease - Acute, Behcet's Disease, Inflammatory Bowel Disease, Celiac Disease, Crohn's Disease - Maintenance, Plaque Psoriasis, Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Spondyloarthritis