Tvardi Therapeutics says its experimental drug TTI-101 failed to show benefit in a Phase 2 clinical trial for idiopathic pulmonary fibrosis.
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...