墨尔本的Telix制药公司向美国FDA提交了TLX101-CDx (Pixclara) 膠原瘤成像剂的NDA. Melbourne's Telix Pharmaceuticals submits NDA for glioma imaging agent TLX101-CDx (Pixclara) to US FDA.

墨尔本的Telix制药公司已向美国FDA提交了其脑癌成像剂TLX101-CDx (Pixclara) 的新药申请 (NDA),用于成人和儿童质瘤患者. Melbourne's Telix Pharmaceuticals has submitted a New Drug Application (NDA) for its brain cancer imaging agent, TLX101-CDx (Pixclara), to the US FDA for use in adult and pediatric glioma patients. Pixclara 拥有孤儿药和快速通道称号，旨在解决神经胶质瘤诊断和管理中未满足的医疗需求。 Pixclara, with Orphan Drug and Fast Track designations, aims to address an unmet medical need in glioma diagnosis and management. 林业发展局没有批准美国成人和儿科脑癌成像的氨基酸PET剂。 The FDA has no approved targeted amino acid PET agent for adult and pediatric brain cancer imaging in the US.