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日電-Incell Corp：*禮來公司和Incell Communications審查延長巴利替尼治療中重度特應性皮炎的補充新藥申請*Incell Corp-處方藥使用費ACT(PDUFA)行動日期已延長三個月，至2021年第三季度初。*Incell Corp-FDA延長了行動日期，以便有時間審查禮來公司應最近的信息請求提交的額外數據分析*Incell Corp-Extension不影響禮來公司之前發佈的2021年財務指引Eikon的源文本：進一步的公司報道：(路透社消息：Reurs.Briefs@thomsonreurs.com)
譯文內容由第三人軟體翻譯。
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