Fibrogen’s controversial anaemia pill becomes the latest example of markedly different regulatory stances taken in Europe and the US.
According to Sesen Bio Vicineum was a shoo-in for US approval this month. What went so badly wrong?
The business split is still on, but problems mount for the genetic disease wing of Bluebird.
Memed claims that its newly CE-marked test can predict Covid-19 severity.
Biogen goes on the offensive against “misinformation” and a media assault, but Roche says patients want clinical benefit, “not imaging”.
An FDA advisory committee refuses to overlook the potential dangers of roxadustat, Fibrogen's novel anaemia pill, leaving partner Astrazeneca with a difficult…
The practicalities of actually selling the controversial new Alzheimer’s drug are proving increasingly difficult for Biogen.
A scorchingly positive adcom was somewhat unexpected given the FDA’s scepticism in the briefing documents.
In an unprecedented situation Biogen sought to restrict the use of Aduhelm weeks after the drug’s approval. And the FDA said yes.