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FDA issues CRL for Telix’s kidney cancer imaging agent

Sep. 2, 2025

Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).

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

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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...