J&J will use a 160,000ft² manufacturing facility at Fujifilm’s new manufacturing hub in Holly Springs, North Carolina. Credit ...

Before Novo arrived as its owner, issues at the Bloomington facility caused a two-month delay for Eylea HD’s FDA approval decision in 2023. In November 2024, the FDA also found quality control lapses ...

Keros received orphan drug designation from the US FDA for its investigational therapy KER-065 to treat Duchenne muscular dystrophy (DMD).