FDA Claims ‘Manipulated’ Data Led to Drug’s Approval, Proposes Withdrawal
(MedPage Today) -- The FDA said that "manipulated" data supported the approval of avacopan (Tavneos) for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated ...
Tag: approval
FDA Expands Approval of Drug to Stave Off Type 1 Diabetes
(MedPage Today) -- The FDA expanded the approval for teplizumab (Tzield), a biologic that delays the progression of preclinical type ...
New GLP-1 Pill Wins Speedy Approval for Weight Loss
(MedPage Today) -- The FDA has approved a second oral GLP-1 receptor agonist for weight loss in adults with obesity ...
High-Dose Wegovy Wins FDA Approval
(MedPage Today) -- The FDA approved a higher dose of the GLP-1 receptor agonist semaglutide for weight loss, dubbed Wegovy ...
First-of-Its-Kind Device for Pancreatic Cancer Wins FDA Approval
(MedPage Today) -- The FDA approved a tumor treating fields (TTFields) device for locally advanced pancreatic cancer, the first therapy ...
Agios Pharma shares jump as U.S. FDA expands approval for blood disorder drug
Aqvesme is expected to be available late next month, following the implementation of a required safety programme Source: Read full ...