The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Advanz Pharma’s combined antibiotic, cefepime/enmetazobactam, to treat complicated infections.
The United States regulator has signed off on Allecra Therapeutics’ Exblifep (cefepime/enmatazobactam) as a treatment for cUTIs, including the severe kidney condition pyelonephritis, brought on by gram-negative bacteria.
Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam
New England Journal of Medicine Publishes Positive Results of Cefepime-Taniborbactam from Phase 3
Venatorx and Menarini Enter Agreement for Cefepime-Taniborbactam
SHANGHAI, Aug. 15, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK)'s partner Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic for the potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis. The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of Feb. 22, 2024.
Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults
CHICAGO--(BUSINESS WIRE)--Xentria Inc., a clinical-stage biotherapeutics company focused on developing therapeutics to address unmet clinical needs, and Meitheal Pharmaceuticals, Inc.1, today announced an exclusive multi-year licensing agreement to commercialize its lead candidate, and novel biologic, XTMAB-16 for pulmonary sarcoidosis in North America.
Enforcement Report - Week of May 24, 2023