Posted by Michael Wonder on 27 Jun 2022
U.S. FDA declines to approve Spero's urinary tract infection drug
27 June 2022 - The U.S. FDA declined to approve Spero Therapeutics' oral antibiotic drug for the treatment of patients with complicated urinary tract infections, the company said on Monday.
In the complete response letter, the health regulator concluded that Spero's late-stage study testing the drug was insufficient and an additional study would be required, the drugmaker said.
