德国公司寻求FDA批准Gleolan以改善脑膜瘤手术的可视化. German-owned firm seeks FDA approval for Gleolan to improve meningioma surgery visualization.

美国NX开发公司向FDA提交了Gleolan的补充新药申请,寻求批准在手术期间改善脑膜瘤的可视化. NX Development Corp submitted a supplemental new drug application to the FDA for Gleolan, seeking approval to improve the visualization of meningioma during surgery. 这是自2017年批准用于高度质瘤以来的首个有效补充剂. This marks the first efficacy supplement since the drug’s 2017 approval for high-grade glioma. 这家公司现在由SBI Holdings的德国子公司拥有, 强调了这一数据作为光指导手术的一个里程碑的重要性. The company, now owned by a German subsidiary of SBI Holdings, emphasized the significance of the data as a milestone for fluorescence-guided surgery.