美国食品和药物管理局接受对Pixclara®的优先审查,PET成像剂用于质瘤,定于2025年推出. FDA accepts priority review for Pixclara®, a PET imaging agent for gliomas, set for 2025 launch.

美国食品和药物管理局已接受TLX101-CDx (Pixclara®) 的新药申请,该药物是用于质瘤的PET成像剂,并给予其优先审查. The FDA has accepted the New Drug Application for TLX101-CDx (Pixclara®), a PET imaging agent for gliomas, and granted it priority review. Pixclara的目标是加强对这些常见脑肿瘤的诊断和治疗。 Set for a potential commercial launch in 2025, Pixclara aims to enhance diagnosis and treatment for these common brain tumors. 它被指定为一种孤儿药物,它解决了目前成像方法无法满足的重大医疗需要,这些方法在显微镜管理方面有局限性。 Designated as an orphan drug, it addresses significant medical needs not met by current imaging methods, which have limitations in glioma management.