Zykadia first received accelerated approval in 2014 for patients with ALK-positive metastatic NSCLC who progressed on or are intolerant to crizotinib.
Naci的研究团队分析了获得FDA加速批准上市的22种药物,这些药物对应24种适应症。
Dr. Naci's team analyzed the FDA's accelerated approval of 22 drugs for 24 medical conditions.
为了加速批准进程,挪威通过在维也纳的筹备委员会向有关国家提供了资金援助。
In order to accelerate the ratification process Norway has granted financial assistance to selected countries, through the Preparatory Commission in Vienna.
为了加速批准进程,挪威通过设在维也纳的筹备委员会,向44国名单中的部分国家提供了财政援助。
In order to accelerate the ratification process Norway has granted financial assistance to selected countries in the list of 44 states, through the Preparatory Commission in Vienna.
FDA的加速批准下,药品生产企业必须验证并进一步描述治疗的临床效益。
Under FDA's accelerated approval, the drug manufacturer must verify and further describe the clinical benefit of the treatment.
委员会继续努力加速批准有关石油部门所需备件和设备的申请书。
The Committee has made continuous efforts to expedite the approval of applications for oil spare parts and equipment required for the oil sector.
会议还审议了加速批准进程的措施,以促进条约早日生效。
It had also considered measures to accelerate the ratification process in order to facilitate the Treaty' s early entry into force.
与以前各阶段一样,委员会继续努力加速批准为石油业提供备件和设备的申请。
The Committee has, as in the previous phases,made continuous efforts to expedite the approval of applications for oil spare parts and equipment required for the oil sector.
加速批准1993年《跨国收养方面保护儿童及合作海牙公约》。
(c) Expedite the ratification of the 1993 Hague Convention on Protection of Children and Cooperation in respect of Intercountry Adoption.
根据FDA的加速批准法规,此次批准是基于肿瘤缓解率和无进展生存期(PFS)数据。
Under the FDA's accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival(PFS).
加速批准农业生物技术新产品不仅惠及美国,更使全.
Expeditious approval of new products of agri-biotechnology benefits not only the USA, but also the global community.
加紧努力,加速批准《国际刑事法院罗马规约》等文书(葡萄牙)。
Step up efforts to accelerate the ratification of, among others, the Rome Statute of the International Criminal Court(Portugal);
委员会建议缔约国加速批准这两项《公约任择议定书》。
The Committee recommends that the State party expedite the ratification of the two Optional Protocols to the Convention.
斯里兰卡政府同意审查限制物品清单和研究加速批准必要用品分发的程序。
The Government agreed to review the list of restricted items andto examine procedures to expedite the approval and distribution of necessary supplies.
加速批准农业生物技术新产品不仅惠及美国,更使全球社区受益。
Expeditious approval of new products of agri-biotechnology benefits not only the USA, but also the global community.
Mylotarg能够在2000年获得加速批准,主要是因为AML患者当时的治疗选择非常有限。
Mylotarg was able to get accelerated approval in 2000, mainly because AML patients had very limited treatment options at the time.
各缔约国还同意按照国际法采取一切可能的措施,加速批准进程,以促进该条约早日生效。
The States parties further agree to pursue allpossible measures consistent with international law to accelerate the ratification process in order to facilitate the early entry into force of this Treaty.
这个适应是根据无进展生存(PFS)在加速批准下被批准。
This indication is approved under accelerated approval based on progression-free survival(PFS).
The U.S. Food and Drug Administration on December 19,2016 granted accelerated approval to Rubraca(rucaparib) to treat women with a certain type of ovarian cancer.
的药物获得FDA常规批准,而其余的药物则获得了加速批准。
Of the drugs received regular approval from FDA,while the rest received accelerated approval.
加速批准有关预防侵害妇女的暴力、强奸和歧视行为的国际公约;.
(a) Expediting the ratification of international instruments dealing with the prevention of violence, rape and discrimination against women;
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