A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.

The 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.

The U.S. FDA cleared Achaogen’s antibiotic to treat adults with complicated urinary tract infections, but the drug failed to win approval for treating bloodstream infections.

The U.S. Food and Drug Administration approved Medicines Co.’s antibacterial drug for patients with complicated urinary tract infections (cUTI).