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Enbrel News
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...
Major Drug Companies Agree to Price Negotiations With U.S. Government
TUESDAY, Oct. 3, 2023 – Pharmaceutical companies that make the 10 prescription drugs chosen to be the first for price negotiations for Medicare patients have agreed to talks with the government. The...
FDA Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel
INCHEON, Korea – As of April 2019 – Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved Eticovo (etanercept-ykro), a biosimilar referencing Enbrel (et...
FDA Approves Expanded Use of Enbrel (etanercept) to Treat Children with Chronic Moderate-To-Severe Plaque Psoriasis
THOUSAND OAKS, Calif., Nov. 4, 2016 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application...
FDA Approves Erelzi (etanercept-szzs), a Biosimilar to Enbrel
August 30, 2016 – The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was...
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 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...
FDA Medwatch Alert: Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)
[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently...
FDA Medwatch Alert: Enbrel (etanercept)
[Posted 05/01/2008] Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections,...
FDA Medwatch Alert: Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of...
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