美国食品和药物管理局优先审查新型肺癌药物塔莱特雷克提尼布,目标在2025年6月之前获得批准.
The FDA grants priority review for a new lung cancer drug, taletrectinib, aiming for approval by June 2025.
美国食品和药物管理局已经对Nuvation Bio的申请给予优先审查,该申请是针对taletrectinib,这是一种治疗ROS1阳性高级非小细胞肺癌的新药.
The FDA has granted a priority review for Nuvation Bio's application for taletrectinib, a new drug for advanced ROS1-positive non-small cell lung cancer.
批准程序旨在加快提供潜在的新疗法,目标是在2025年6月23日前完成。
The approval process, which aims to expedite the availability of potential new therapies, is targeted for completion by June 23, 2025.
这一决定基于第二阶段研究的数据,而Nuviation Bio的库存在市场前贸易中增长了4.43%。
The decision is based on data from Phase 2 studies, and Nuvation Bio's stock saw a 4.43% increase in pre-market trading.