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Telix setback in drug approval in US, amid Trump workforce cuts to FDA

Telix setback in drug approval in US, amid Trump workforce cuts to FDA

Telix Pharmaceuticals says it is disappointed by a surprise US Food and Drug Administration decision to ask for more clinical evidence to support approval for its brain cancer imaging agent, a rare setback for the $9 billion ASX-listed diagnostic giant.
Telix shares fell as much as 10 per cent in early trading on Monday after the FDA said it would not approve the company's diagnostic tool called Pixclara, which identifies gliomas, a deadly form of brain cancer, until the company provided additional evidence about its benefits.

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