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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

Today's news in brief

BioWorld

BioWorld briefs for Dec. 18, 2025.

Today's news in brief

BioWorld MedTech

BioWorld MedTech briefs for Dec. 18, 2025.

Left: Anthony Fauci. Right: Transmission electron micrograph of HIV-1 virus particles

HIV research is close to a cure but far from ending the pandemic

BioWorld

Advances in antiretroviral therapy (ART) now allow people living with HIV to lead normal lives with undetectable and nontransmissible levels of the virus in their...

European Commission floats multiple fixes for MDR, IVDR

BioWorld MedTech

The European Union’s struggles with regulations for devices and in vitro diagnostics seem virtually endless, but the European Commission floated a series of...

Decorative scales of justice in a courtroom

DOJ arrests shed light on Medicare skin substitute controversy

BioWorld MedTech

Much has been made of the recent skyrocketing of Medicare spending on skin substitutes, but a new enforcement action by the U.S. Department of Justice might help...