Mallinckrodt has finally claimed FDA approval for terlipressin as a treatment for hepatorenal syndrome (HRS), after manufacturing problems scuppered an earlier attempt.
Bristol-Myers Squibb's deucravacitinib – one of the main pipeline assets in its $74 billion takeover of Celgene in 2019 – has been approved in its first market as a treatme
Gilead Sciences' Kite Pharma unit has carved out a niche for its CD19-targeted CAR-T therapy Tecartus in acute lymphoblastic leukaemia (ALL) in Europe, free of direct competition from arch-
Sanofi now has approval on both sides of the Atlantic for Xenpozyme – its enzyme replacement therapy for rare disease acid sphingomyelinase deficiency (ASMD) – after getting a green light f
BioMarin Pharma has its landmark first approval for Roctavian – the first for a haemophilia gene therapy – and will now have to see if that can convert that into a viable business in Europe
Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with