Regeneron says new clinical data show its investigational gene therapy DB-OTO has restored meaningful hearing in nearly all children treated for rare ...
FDA extends by three months its review of a Denali Therapeutics BLA for tividenofusp alfa, a potential treatment for Hunter syndrome.
FDA approves an expanded indication for Medtronics Endurant II/IIs Stent Graft System, allowing its use in abdominal aortic aneurysm patients with sho...
FDA grants BeOne Medicines a breakthrough therapy designation for sonrotoclax and its use in treating adults with relapsed or refractory mantle cell l...
FDA assigns an Official Action Indicated classification to a recent inspection of a Novo Nordisk manufacturing facility in Bloomington, IN.
AbbVie gains an updated label for Rinvoq (upadacitinib), expanding its use in treating adults with moderately to severely active ulcerative colitis an...
FDA approves Celltrions Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron and Bayers blockbuster Eylea for treating several major retin...
