Regulation - Eliquis, North America

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“Breakthrough Therapy” status for Portola’s andexanet alfa

25-11-2013

USA-based Portola Pharmaceuticals has been granted “Breakthrough Therapy” designation by the US Food…

andexanet alfaBayerBristol-Myers SquibbCardio-vascularEliquisNorth AmericaPharmaceuticalPortola PharmaceuticalsRegulationResearchXarelto

US FDA accepts Bristol-Myers/Pfizer' Eliquis sNDA

12-07-2013

US pharma major Bristol-Myers Squibb (NYSE: BMY) and behemoth Pfizer (NYSE: PFE) announced that the US…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

US FDA finally approves Bristol-Myers/Pfizer's Eliquis for stroke prevention in AF patients

31-12-2012

The US Food and Drug Administration on December 28 finally approved the anti-clotting drug Eliquis (apixaban),…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

FDA sets March 2013 PDUFA date for re-submitted Eliquis

28-09-2012

The US Food and Drug Administration has acknowledged receipt of the New Drug Application resubmission…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

FDA again delays approval of Bristol-Myers and Pfizer's Eliquis

26-06-2012

A few days ahead of the expected decision date, the US Food and Drug Administration on Monday issued…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

US FDA delays Eliquis decision; Pristiq dropped for menopause

02-03-2012

USA drug major Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE) say that the US Food and…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalPristiqRegulationWomen's Health

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