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Endpoints·1h ago·1 min read
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UK regulator suspends Tavneos sales as MHRA follows EMA decision; UniQure files for Huntington's gene therapy approval

Sep 2, 2026·read at Endpoints ↗RegulatoryNegative

The UK Medicines and Healthcare products Regulatory Agency has ordered a halt to the sale of the drug Tavneos, citing concerns that align with a recent decision by the European Medicines Agency.

The agency said the suspension follows the EMA's earlier recommendation, indicating ongoing safety or efficacy questions that need to be addressed before the product can be marketed in the UK.

In a separate development, gene-therapy company UniQure submitted a regulatory filing in the United Kingdom seeking approval for its experimental treatment for Huntington's disease.

The briefing also noted that other companies such as Regeneron, Novocure, Jazz, BioMarin, Ascendis, AstraZeneca, Hutchmed and TScan Therapeutics were mentioned, but no further details were provided.

source

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

Original headline: “UK regulator halts sales of Tavneos; UniQure seeks approval for Huntington's gene therapy”

read at Endpoints ↗
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companies & drugs in this story

companies
Jazz Pharmaceuticals plc3ASCENDIS2ASTRAZENECA2NOVOThe Medicines Co
drugs
avacopan5zanidatamab
topics
Approval2Huntington's2Gene Therapy (AAV)

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