Has 2020 been a big year for regulatory knockbacks?
An analysis of FDA complete response letters does not reveal a big uptick – but the year is not over yet.
Is valrox dead?
Valrox leaves a disproportionate hole in Biomarin’s valuation, but gene therapy competitors shouldn’t celebrate just yet.
Filgotinib setback vindicates Abbvie’s opt-out
A shock US rejection delays approval by at least two years and makes Abbvie, which had given up rights five years ago, look smart.
The dream is over for Intercept
The company blasts the US regulator as weeks of uncertainty for its lead drug in Nash end in a complete response letter.
