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Endpoints·8h ago·1 min read
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European regulators withdraw Amgen's Tavneos over questionable data

Aug 13, 2026·read at Endpoints ↗RegulatoryNegative

European regulators announced they are pulling Amgen's rare disease drug Tavneos from the European market after reviewing data they deemed incorrect and misleading.

The authorities said the data supporting the drug's efficacy and safety were not reliable, leading to skepticism and the decision to remove the product.

Amgen had previously marketed Tavneos for a rare disease, but the withdrawal reflects regulatory concerns and may affect the company's European operations.

The move underscores the importance of robust clinical data for drug approvals and could influence investor sentiment toward Amgen.

source

This writeup was produced by pharmadog from original reporting by Endpoints.

Original headline: “'Incorrect and misleading' data prompted decision to pull Tavneos in Europe”

read at Endpoints ↗
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companies & drugs in this story

companies
AMGEN4Ultragenyx Pharmaceutical Inc.4Sionna Therapeutics, Inc.2LEADINGVyome Holdings, Inc
drugs
avacopan6Rare Disease3
topics
Rare Disease4

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