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此次批准是基于IMpassion130试验的研究结果。
This approval is based on the results from the Phase III IMpassion130 study.
此次批准,基于III期IMpower133研究的结果。
This approval is based on the results from the phase I/III IMpower133 study.
此次批准,基于III期IMpower133研究的结果。
The FDA based this approval on the data from the phase III IMpower133 trial.
此次批准为这些罕见癌症患者提供了另一个治疗选择。
This approval provides another treatment choice for patients with these rare cancers.
此次批准,是基于III期临床研究iLLuminate(PCYC-1130)的数据。
This approval is based on results from the Phase 3 iLLUMINATE study(PCYC-1130.
此次批准,是基于III期临床研究iLLuminate(PCYC-1130)的数据。
This approval was based on data from the iLLUMINATE(PCYC-1130) trial.
此次批准是赛诺菲在美国完全过渡到四价流感疫苗的最后一步。
This approval is the final step toward the company's complete transition to quadrivalent influenza vaccines in the US.
此次批准不仅支持ALL治疗连续体中早期使用Blincyto,而且代表了ALL管理模式的转变。
This approval not only supports the use of Blincyto earlier in the all treatment continuum, but represents a paradigm shift in the management of all..
此次批准还意味着可持续化森林管理的开始,以较少的资源生产更多的纤维。
This approval also represents the beginning of a new era for sustainable forest management by enabling the production of more fiber, using less resources.
此次批准,使Tracleer成为美国市场中首个获得FDA批准用于治疗儿科PAH的药物。
With this approval, TRACLEER becomes the first FDA-approved medicine for pediatric PAH patients in the United States.
此次批准,也标志着Opdivo成为过去10多年来SQ-NSCLC领域的首个重大治疗进展。
This approval marks the first major treatment advance in SQ NSCLC in more than a decade in the European Union(EU.
此次批准,是基于来自3个III期临床研究(CIMPASI-1,CIMPASI-2,CIMPACT)的数据。
The FDA approval of Cimzia is based on data from three Phase III clinical studies: CIMPASI-1, CIMPASI-2, and CIMPACT.
此次批准,是基于来自3个III期临床研究(CIMPASI-1,CIMPASI-2,CIMPACT)的数据。
The FDA's approval for CIMZIA® was based on the data from three Phase III clinical trials named CIMPASI-1, CIMPASI-2 and CIMPACT.
此次批准,使Humira成为5年多来获批用于这一患者群体的首个生物治疗药物。
With this approval, HUMIRA becomes the first biologic treatment approved for these patients in more than five years.
此次批准(40mg皮下注射制剂),将Nucala目前在美国的适用人群扩展至6-11岁的患者。
This approval(40mg dose subcutaneous injection) extends the current indication in the US for Nucala to patients aged six to 11 years.
此次批准提醒人们,推进健康发展计划,正确评估大麻中含有的活性成分,可以带来重要的治疗药物。
This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.
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.
此次批准对中国患者而言标志着一个重大进步,这些患者现在有了一种新的、急需的治疗方案。
This approval marks an important development for patients in China, who now have the benefit of a new and much needed treatment option.
此次批准也将Venclexta的加速批准转为了完全批准。
This FDA combination approval converts Venclexta's previous accelerated approval to a full approval..
此次批准为MF患者提供了一种新的治疗选择,并且是FDA首次专门针对SS的药物批准。
This approval provides a new treatment option for patients with MF and is the first FDA-approved drug specifically for SS.