Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysi
Orphazyme's hopes of getting EU approval for its Niemann-Pick disease type C (NPC) therapy arimoclomol after a rejection by the US FDA last year are dwindling fast.
Manufacturing problems seem to have scuppered Mallinckrodt's hopes of bringing the first approved drug to market in the US for hepatorenal syndrome (HRS), a life-threatening condition that
AbbVie has filed with the FDA to extend the uses of its bipolar disorder therapy Vraylar to include adjunctive therapy for major depressive disorder, part of a plan to build sales of the dr
The FDA has approved expanded labelling for Abbott's CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could make it an option for
Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival th
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.