
FDA Issues CRL to TLX101-CDx for Glioma Imaging
The FDA has issued a complete response letter (CRL) to the new drug application (NDA) seeking the approval of TLX101-CDx (18F-floretyrosine [18F-FET]; Pixclara) for use in the imaging of glioma.1 After reviewing the NDA, the FDA informed Telix …