April 4, 2018 / 12:02 PM / 3 months ago

BRIEF-U.S. FDA And European Medicines Agency Accept Regulatory Submissions For Review Of Dacomitinib

April 4 (Reuters) - Pfizer Inc:

* ACTIVATING MUTATIONS

* ‍PRESCRIPTION DRUG USER FEE ACT (PDUFA) GOAL DATE FOR A DECISION BY FDA IS IN SEPTEMBER 2018​

* ‍EUROPEAN MEDICINES AGENCY HAS ALSO ACCEPTED MARKETING AUTHORIZATION APPLICATION FOR DACOMITINIB FOR SAME INDICATION​ Source text for Eikon: Further company coverage: (Reuters.Brief@thomsonreuters.com)

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