Portola Pharma (PTLA) Says IndexXa MAA Accepted for Review in Europe
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Portola Pharma (PTLA) Receives CRL from FDA for Andexanet Alfa
August 18, 2016 6:16 AM EDTPortola Pharmaceuticals Inc. (Nasdaq: PTLA) announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to... More
Portola Pharma (PTLA) Drops 21% With Andexanet PDUFA Looming
August 17, 2016 3:29 PM EDTPortola Pharma (NASDAQ: PTLA) declined over 20% and was halted on a limit-down pause Wednesday. The company's andexanet alfa PDUFA is today, August 17, 2016. The PDUFA date is the goal date for the FDA to complete its review of the BLA.
... MorePortola Pharma (PTLA) Halted on LUDP
August 17, 2016 3:14 PM EDTPortola Pharma (NASDAQ: PTLA) Halted on LUDP
... More
