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BRIEF-Lilly And Incyte Communicate Review Extension Of Supplemental NDA For Baricitinib

路透社 ·  Apr 7, 2021 04:49
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

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((Reuters Messaging: Reuters.Briefs@thomsonreuters.com)
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