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 ...

In June 2022, Enanta filed a lawsuit against Pfizer in a US district court in Massachusetts, claiming that the big pharma ...

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