BRIEF-AstraZeneca Says U.S. Extends Review Period Of Lynparza-Combo For Prostate Cancer

AstraZeneca PLC: * UPDATE ON US REVIEW OF LYNPARZA PROPEL SNDA * UPDATE ON US REGULATORY PRIORITY REVIEW OF LYNPARZA IN COMBINATION WITH ABIRATERONE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER * FDA HAS INFORMED ASTRAZENECA THAT IT WILL EXTEND PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE BY THREE MONTHS * COMPANIES WILL CONTINUE TO WORK WITH FDA TO FACILITATE COMPLETION OF AGENCY'S REVIEW.

BRIEF-AstraZeneca Says U.S. Extends Review Period Of Lynparza-Combo For Prostate Cancer
AstraZeneca logo Image Credit: ANI

AstraZeneca PLC: * UPDATE ON US REVIEW OF LYNPARZA PROPEL SNDA

* UPDATE ON US REGULATORY PRIORITY REVIEW OF LYNPARZA IN COMBINATION WITH ABIRATERONE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER * FDA HAS INFORMED ASTRAZENECA THAT IT WILL EXTEND PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE BY THREE MONTHS

* COMPANIES WILL CONTINUE TO WORK WITH FDA TO FACILITATE COMPLETION OF AGENCY'S REVIEW. * COMBINATION IS ALSO UNDERGOING REGULATORY REVIEWS IN OTHER COUNTRIES. Source text for Eikon: Further company coverage:

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