Telix Pharmaceuticals Ltd. (AU:TLX) has released an update.
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Telix Pharmaceuticals Ltd. has announced that the FDA identified a filing issue related to sterility assurance in its BLA for renal cancer imaging agent TLX250-CDx, requiring remediation. The company expects to address the FDA’s concerns and resubmit within 90 days, with no impact on financial forecasts for the year. Telix remains confident in the product’s commercial launch in 2025, reiterating its commitment to providing access to this potentially first-of-its-kind non-invasive diagnostic tool for renal cancer.
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