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Telix Faces FDA Setback on TLX250-CDx but Eyes Swift Resolution
2:13am on Saturday 30th of August, 2025 AEST
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Healthcare
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Telix Faces FDA Setback on TLX250-CDx but Eyes Swift Resolution
2:13am on Saturday 30th of August, 2025 AEST
Key Points
FDA issues Complete Response Letter over manufacturing comparability
Third-party manufacturing partners flagged for deficiencies
Telix to seek Type A meeting with FDA for resubmission timeline
Breakthrough Therapy and Priority Review status remain intact
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