Enbrel Label Gets “Black Box” On Tuberculosis Risk
This article was originally published in The Pink Sheet Daily
Executive Summary
Package insert for Amgen/Wyeth biologic now more in line with other TNF inhibitors.
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TNF Blocker Fungal Infection: FDA Uses REMS For Relabeling, Education
FDA is using its new drug safety authority to require label changes within 30 days for all four products in the tumor necrosis factor inhibitor class
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FDA is using its new drug safety authority to require label changes within 30 days for all four products in the tumor necrosis factor inhibitor class
FDA Panel To Mull Risks Of Amgen’s Enbrel For Pediatric Psoriasis
Agency’s Dermatologic and Ophthalmic Drugs Advisory Committee also will discuss whether the sponsor submitted sufficient information to extend approval to the pediatric population.