Venatorx Pharmaceuticals Inc. on Aug. 15 said the U.S. FDA accepted its NDA for an intravenous antibiotic combination, cefepime-taniborbactam, to treat complicated urinary tract infection (cUTI), including acute pyelonephritis.
The PDUFA commitment letter negotiated between industry and the U.S FDA every five years provides an inside look at the future of drug development. The PDUFA VII letter, which is to be presented to Congress by Jan. 15, is no exception.
Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before.
