HGS’ Benlysta Wins FDA Approval, First New Lupus Drug in 50 Years

David Belian

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HGS’ Benlysta Wins FDA Approval, First New Lupus Drug in 50 Years

机译：HGS的Benlysta获得FDA批准，这是50年来的首个新狼疮药物

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Human Genome Sciences (HGS) has won FDA approval of its nlupus treatment Benlysta, and Wall Street analysts are already fore-ncasting a blockbuster future for the drug.

机译：人类基因组科学公司（HGS）已获得FDA批准其对狼疮的治疗Benlysta的批准，华尔街分析师已经在预言该药物的重磅炸弹。

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《Washington Drug Letter 》 |2011年第11期| p.1-2| 共2页
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David Belian;
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1. FDA to Act on Benlysta, Rare New Drug for Lupus [J] . Thomas MorrowMD Managed care . 2011 ,第1期

机译：FDA将对Benlysta罕见的狼疮新药采取行动
2. Ending the 50-year drought of FDA drug approval for SLE. [J] . Merrill JT Bulletin of the NYU hospital for joint diseases . 2011 ,第3期

机译：结束了FDA对SLE药物批准的50年干旱。
3. Ending the 50-year drought of FDA drug approval for SLE. [J] . Merrill JT Bulletin of the NYU hospital for joint diseases . 2011 ,第3期

机译：结束了FDA对SLE药物批准的50年干旱。
4. The travail involved in getting FDA approval . . . an overview on what it took to get FDA approval of a medical device with computer technology (A recent experience) [C] . Paul, A. Engineering of Computer-Based Medical Systems, 1988., Proceedings of the Symposium on the . 1988

机译：这次灾难涉及获得FDA批准。。。 FDA批准使用计算机技术的医疗设备所需的概述（最近的经验）
5. Meta-Analysis to Identify and Evaluate Factors Associated with Regulatory Approval of Orphan Drugs (OD) to Develop an Algorithm for Predicting Regulatory Approval (Success) and to Develop a Standardized Tool to Improve Orphan Drug Portfolio Decision-Making [D] . Florent, Milky C. 2019

机译：荟萃分析，以识别和评估与孤儿药物监管批准（OD）相关的因素，以开发预测监管批准（成功）的算法，并开发标准化工具以改善孤儿药物投资组合决策
6. Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs [O] . Janice Kim, Abhilasha Nair, Patricia Keegan, 2020

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7. Does $760m a year of industry funding affect the FDA's drug approval process? [O] . S. M. Wolfe 2014

机译：每年760亿美元的行业资金会影响FDA的药物批准过程吗？
8. FDA Drug Approval: Review Time Has Decreased in Recent Years [R] . 1995

机译：FDa药品批准：近年来审查时间有所减少

HGS’ Benlysta Wins FDA Approval, First New Lupus Drug in 50 Years

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