This month Pliant Therapeutics claimed a win in idiopathic pulmonary fibrosis, but other projects have fallen by the wayside.
But winning EU approval for the novel anaemia pill was not straightforward, the Japanese firm says.
Fibrogen’s controversial anaemia pill becomes the latest example of markedly different regulatory stances taken in Europe and the US.
Axsome and Sanofi face FDA verdicts in depression and Pompe disease respectively, while a Keytruda combo ups the ante in kidney cancer.
An FDA advisory committee refuses to overlook the potential dangers of roxadustat, Fibrogen's novel anaemia pill, leaving partner Astrazeneca with a difficult…
Big regulatory events for July include a panel for Fibrogen's roxadustat and decision time for Albireo; elsewhere, Jak inhibitor delays could persist.