CMC

Manufacturing

Manufacturing issues force PolarityTE to halt skin repair IND

PolarityTE's submission for regenerative therapy SkinTE has been put on hold by the FDA because of chemistry, manufacturing and control concerns.
Kevin Dunleavy Aug 24, 2021 11:06am

FDA puts Altimmune's intranasal COVID-19 vaccine trial on hold

Jan 5, 2021 8:32am

Novavax delays U.S. trial amid FDA manufacturing 'questions'

Nov 30, 2020 10:15am

Bluebird tanks with FDA delay of LentiGlobin in sickle cell

Nov 5, 2020 10:58am

Novavax fleshes out executive team with new manufacturing chief

Jun 30, 2020 9:00am

GSK's long-acting HIV injectable hits FDA snag

Dec 23, 2019 8:45am