To read the full article sign up for free or sign in.

FDA issues CRL for Telix’s kidney cancer imaging agent

Aug. 28, 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 BioWorld MedTech Regulatory Cancer Antibody Diagnostics Asia-Pacific Australia U.S. FDA

Today's news in brief

BioWorld

BioWorld briefs for Dec. 31, 2025.

Today's news in brief

BioWorld MedTech

BioWorld MedTech briefs for Jan. 2, 2026.

AND-017 increases RBC and hemoglobin in sickle cell disease

BioWorld Science

Sickle cell disease (SCD) is an inherited hemoglobinopathy caused by a mutation in the gene encoding β-globin that results in hemoglobin S polymerization, red...

Shionogi nabs revenue-generating ALS drugs with $2.5B Tanabe pact

BioWorld

Shionogi & Co. Ltd. will acquire global rights to U.S. FDA approved amyotrophic lateral sclerosis therapy edaravone through a $2.5 billion acquisition deal with...

Big pharma taps fast Asia innovation in search of next Keytruda

BioWorld

Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab),...