FDA granted accelerated approval 'agence du médicament américaine FDA October 2015 release of Praxbind FDA approved fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm granted accelerated approval fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm Praxbind approved fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm FDA approved Praxbind news release fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm Praxbind Pradaxa accelerated approval FDAのリリース recently Archived copy approval fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm approves accelerated approval FDA press release