Panel puts Fibrogen project to an almost certain death
An FDA advisory committee refuses to overlook the potential dangers of roxadustat, Fibrogen's novel anaemia pill, leaving partner Astrazeneca with a difficult…
Transmedics panel defies expectations
A scorchingly positive adcom was somewhat unexpected given the FDA’s scepticism in the briefing documents.
Novartis leads and Bristol lags on novel drug approvals
Big pharma delivered 76 novel medicines to the market over the past five years, but some companies contributed more than others.
Narrowed label for Biogen’s Aduhelm lays bare FDA’s fail
In an unprecedented situation Biogen sought to restrict the use of Aduhelm weeks after the drug’s approval. And the FDA said yes.
Go or no go? Ardelyx and Chemocentryx among those waiting FDA decisions
Big regulatory events for July include a panel for Fibrogen's roxadustat and decision time for Albireo; elsewhere, Jak inhibitor delays could persist.
Glaxo needs long-acting HIV gamble to pay off
Dolutegravir’s patent expiry will pile on the pressure as Gilead and Merck get on the long-acting bandwagon.
