Shares of Forte Biosciences plunged after announcing that a Phase II atopic dermatitis trial assessing the company’s lead pipeline candidate failed to demonstrate statistical significance in the primary endpoint.
U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections
Antibiotics, Antimicrobial Drugs Advisory Committee, Cephalosporins, Complicated Urinary Tract Infections (cUTI), FDA, FDA/Regulatory, Gram-negative bacteria, New Drug Application (NDA), Prescription Drug User-Fee Act (PDUFA), Pyelonephritis, Recommended For ApprovalThe U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee voted to recommend approval of Shionogi & Co. Ltd.’s investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.