CMC

CRL RTF rejection
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
diagram showing how SkinTE is made

Manufacturing issues force PolarityTE to halt skin repair IND

Aug 24, 2021 11:06am
wildpixelGettyImages

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

Jan 5, 2021 8:32am
Novavax vaccine

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

Nov 30, 2020 10:15am
Bluebird Bio CEO snares 24 million pay package as gene therapy advance

Bluebird tanks with FDA delay of LentiGlobin in sickle cell

Nov 5, 2020 10:58am
Novavax sign

Novavax fleshes out executive team with new manufacturing chief

Jun 30, 2020 9:00am