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CMC
Manufacturing
Savara's lung disease asset hit with FDA refuse-to-file letter
Despite hiring a CCO and sponsoring disease awareness efforts last year, Savara will have to wait a while longer for a potential approval.
Fraiser Kansteiner
May 27, 2025 10:35am
Manufacturing issues force PolarityTE to halt skin repair IND
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