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FDA issues CRL for Telix's glioma imaging agent, wants more data

April 29, 2025

The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.

BioWorld Asia Regulatory Cancer Asia-Pacific Australia U.S. FDA

Today's news in brief

BioWorld

BioWorld briefs for Dec. 5, 2025.

Today's news in brief

BioWorld MedTech

BioWorld MedTech briefs for Dec. 5, 2025.

Epigenetic technology could eliminate misfolded prion proteins

BioWorld Science

The number of deaths caused by prion diseases reaches about 30,000 annually. Only 5 months pass from the diagnosis of seemingly healthy patients to the fatal...

Mesothelin is biomarker, potential target in arthritic bone damage

BioWorld Science

In a recent study published in Cell Reports Medicine, researchers from the Institute of Chinese Materia Medica of the China Academy of Chinese Medical Sciences...

Gene therapies aim for the big goal of edits in vivo

BioWorld Science

The field of gene therapy is experiencing major advances driven by precise editing technologies, such as base and prime editing, and by the design of increasingly...