BRIEF-Lilly And Incyte Communicate Review Extension Of Supplemental NDA For Baricitinib
BRIEF-Lilly And Incyte Communicate Review Extension Of Supplemental NDA For Baricitinib
* LILLY AND INCYTE COMMUNICATE REVIEW EXTENSION OF SUPPLEMENTAL NEW DRUG APPLICATION FOR BARICITINIB FOR THE TREATMENT OF MODERATE TO SEVERE ATOPIC DERMATITIS
* INCYTE CORP - PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE HAS BEEN EXTENDED THREE MONTHS TO EARLY Q3 2021.
* INCYTE CORP - FDA EXTENDED ACTION DATE TO ALLOW TIME TO REVIEW ADDITIONAL DATA ANALYSES SUBMITTED BY LILLY IN RESPONSE TO RECENT INFORMATION REQUESTS
* INCYTE CORP - EXTENSION DOES NOT AFFECT LILLY'S PREVIOUSLY-ISSUED FINANCIAL GUIDANCE FOR 2021
Source text for Eikon: Further company coverage:
((Reuters Messaging: Reuters.Briefs@thomsonreuters.com)
April 6 (Reuters) - Incyte Corp :
* LILLY AND INCYTE COMMUNICATE REVIEW EXTENSION OF SUPPLEMENTAL NEW DRUG APPLICATION FOR BARICITINIB FOR THE TREATMENT OF MODERATE TO SEVERE ATOPIC DERMATITIS
* INCYTE CORP - PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE HAS BEEN EXTENDED THREE MONTHS TO EARLY Q3 2021.
* INCYTE CORP - FDA EXTENDED ACTION DATE TO ALLOW TIME TO REVIEW ADDITIONAL DATA ANALYSES SUBMITTED BY LILLY IN RESPONSE TO RECENT INFORMATION REQUESTS
* INCYTE CORP - EXTENSION DOES NOT AFFECT LILLY'S PREVIOUSLY-ISSUED FINANCIAL GUIDANCE FOR 2021
Source text for Eikon: Further company coverage:
((Reuters Messaging: Reuters.Briefs@thomsonreuters.com)
路透4月6日电-Incell Corp：*礼来公司和Incell Communications审查延长巴利替尼治疗中重度特应性皮炎的补充新药申请*Incell Corp-处方药使用费ACT(PDUFA)行动日期已延长三个月，至2021年第三季度初。*Incell Corp-FDA延长了行动日期，以便有时间审查礼来公司应最近的信息请求提交的额外数据分析*Incell Corp-Extension不影响礼来公司之前发布的2021年财务指引Eikon的源文本：进一步的公司报道：(路透社消息：Reurs.Briefs@thomsonreurs.com)
译文内容由第三方软件翻译。
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