MSD’s sotatercept has become the first FDA-approved therapy for pulmonary arterial hypertension (PAH) that addresses the underlying mechanism behind the disease, rather th
AstraZeneca’s Ultomiris has been approved by the FDA to treat rare autoimmune disease neuromyelitis optica spectrum disorder (NMOSD), six months after an earlier applicati
The FDA has turned down a pair of marketing applications for Regeneron’s CD20xCD3 bispecific antibody odronextamab to treat two common forms of non-Hodgkin lymphoma (NHL).
Three digital health technologies (DHTs) used to support patients with psychosis can be used by the NHS while additional evidence of their benefits is gathered.
The March meeting of the EMA’s human medicines committee (CHMP) saw an approval recommendation for Novartis’ Fabhalta, on track to become the first oral monotherapy for ra
Around 14 months after Eisai and Biogen’s Leqembi was filed for approval in the EU, the bloc’s regulatory authority has delayed making a decision on the Alzheimer’s drug.