Telix制药公司提交FDA申请Zircaix,这是一种新的肾癌成像药物。 Telix Pharmaceuticals submits FDA application for Zircaix, a new kidney cancer imaging drug.

Telix制药公司向林业发展局提交了一种肾癌成像药物TLX250-CDx(Zircaix)的生物学许可证申请。 Telix Pharmaceuticals has submitted a Biologics License Application to the FDA for TLX250-CDx (Zircaix®), a kidney cancer imaging drug. 如果获得批准,这将是美国首例针对肾癌的PET剂,旨在诊断和定性清晰的细胞肾脏细胞癌。 If approved, it will be the first targeted PET agent for kidney cancer in the U.S., aimed at diagnosing and characterizing clear cell renal cell carcinoma. 该药物成功地以很高的精确率通过了第三阶段试验。 The drug successfully passed a Phase III trial with high accuracy rates. 在确定决定日期之前,FDA将在60天内审查申请. The FDA will review the application over 60 days before setting a decision date.