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FDA issues refusal to file letter for Telix imaging agent

Aug. 1, 2024

Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).

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

Today's news in brief

BioWorld

BioWorld briefs for Nov. 12, 2025.

Today's news in brief

BioWorld MedTech

BioWorld MedTech briefs for Nov. 12, 2025.

‘Most complete’ map of oral microbiome enables links to systemic disease

BioWorld

South Korean researchers led by Lee In-suk of Yonsei University have reported the most complete oral microbiome catalog to date, with more than 72,000 genomes....

Antibody-drug conjugates floating on light purple background

Sutro Biopharma outlines ADC pipeline

BioWorld Science

Sutro Biopharma Inc. has outlined its next-generation antibody-drug conjugate (ADC) pipeline following recent IND clearance and initiation of phase I for its...

Gentibio’s GNTI-823 promotes renal repair in AKI models

BioWorld Science

Gentibio Inc. has developed and presented data for GNTI-823, an allogeneic tissue Treg engineered from peripheral blood CD4+ T cells with CRISPR-based editing to...