An FDA advisory committee refuses to overlook the potential dangers of roxadustat, Fibrogen's novel anaemia pill, leaving partner Astrazeneca with a difficult…
A scorchingly positive adcom was somewhat unexpected given the FDA’s scepticism in the briefing documents.
Big pharma delivered 76 novel medicines to the market over the past five years, but some companies contributed more than others.
In an unprecedented situation Biogen sought to restrict the use of Aduhelm weeks after the drug’s approval. And the FDA said yes.
Big regulatory events for July include a panel for Fibrogen's roxadustat and decision time for Albireo; elsewhere, Jak inhibitor delays could persist.
Dolutegravir’s patent expiry will pile on the pressure as Gilead and Merck get on the long-acting bandwagon.