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BRIEF-ULTRAGENYX AND KYOWA HAKKO KIRIN ANNOUNCE FDA ACCEPTANCE OF BUROSUMAB’S BIOLOGICS LICENSE APPLICATION
2017年10月10日 / 下午12点45分 / 9 天前

BRIEF-ULTRAGENYX AND KYOWA HAKKO KIRIN ANNOUNCE FDA ACCEPTANCE OF BUROSUMAB’S BIOLOGICS LICENSE APPLICATION

Oct 10 (Reuters) - Ultragenyx Pharmaceutical Inc:

* ULTRAGENYX AND KYOWA HAKKO KIRIN ANNOUNCE FDA ACCEPTANCE AND PRIORITY REVIEW DESIGNATION OF BUROSUMAB’S BIOLOGICS LICENSE APPLICATION

* ULTRAGENYX PHARMACEUTICAL INC - ‍PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE FOR BLA IS APRIL 17, 2018​

* ULTRAGENYX PHARMACEUTICAL INC - FDA HAS NOT INFORMED COMPANIES WHETHER AN ADVISORY COMMITTEE MEETING TO DISCUSS APPLICATION WILL BE NEEDED​

* ULTRAGENYX - FDA ACCEPTED BLA FOR BUROSUMAB TO TREAT PEDIATRIC, ADULT PATIENTS WITH X-LINKED HYPOPHOSPHATEMIA, GRANTED PRIORITY REVIEW STATUS​ Source text for Eikon: Further company coverage:

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