FDA Issues CRL for Telix’s Breakthrough Kidney Cancer Imaging Agent TLX250-CDx Over Manufacturing Concerns
The FDA has issued a Complete Response Letter for TLX250-CDx (Zircaix), rejecting the biologics license application for this breakthrough therapy-designated PET imaging agent due to chemistry, manufacturing, and controls deficiencies rather than clinical efficacy concerns. Telix believes these manufacturing comparability issues are readily addressable, maintaining the drug’s potential as the first commercial imaging agent for […]
