Tag archive for ‘AncexXa PDUFA extended to May 4’
Portola Announces a Delay in PDUFA Date for AndexXa (PTLA, Buy, $54.86)
Portola announced after the close on December 22, 2017 that the FDA will extend its review of AndexXa (andexanet alfa) by 90 days. According to the Company, it just submitted additional data requested by the agency for the ongoing ANNEXA-4 study as part of the continuing review process. This constitutes an amendment to the submission […]