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FDA proposes to withdraw Amgen's rare autoimmune disease drug
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FDA proposes to withdraw Amgen's rare autoimmune disease drug
Apr 27, 2026 6:31 PM

April 27 (Reuters) - The U.S. Food and Drug

Administration's Center for Drug Evaluation and Research on

Monday proposed withdrawing approval of Amgen's ( AMGN ) drug

for a group of rare autoimmune diseases, citing a lack of proven

effectiveness and untrue statements in the application that led

to its approval.

In March, the FDA said it identified 76 cases of drug-induced

liver injury with evidence suggesting a causal link to Tavneos,

including seven cases of vanishing bile duct syndrome (VBDS), a

rare condition that can cause permanent liver damage. Eight

deaths were reported among those cases.

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