GlaxoSmithKline Plc started a late-stage study testing the company’s experimental antibiotic gepotidacin in patients with urinary tract infections and gonorrhoea.
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.
Verrica Pharmaceuticals Inc. submitted a New Drug Application to the U.S. Food and Drug Administration for VP-102 (cantharidin 0.7% topical solution) for the treatment of molluscum contagiosum.
First Antibiotic With New Mechanism of Action Approved in Almost 20 Years
Antibiotics, Approvals, Community-Acquired Bacterial Pneumonia (CABP), Emergency Departments, Emergency Rooms, European Medicines Agency (EMA), Fast Track Designation, FDA, FDA/Regulatory, Priority Review, U.S. Centers for Disease Control and Prevention, Wholesale Acquisition CostThe U.S. FDA gave Nabriva Therapeutics a thumbs-up for the company’s oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.
The U.S. Food and Drug Administration approved TB Alliance’s treatment for drug-resistant tuberculosis as part of a three-drug combination regimen called BPaL.
RedHill Biopharma Ltd. announced that the U.S. Food and Drug Administration accepted for review the New Drug Application for Talicia (RHB-105) for H. pylori infection.
Scientists studying a bacterium that causes scarlet fever, severe sore throat and a form of heart disease are developing a vaccine that could prevent hundred of thousands of infections a year.
Merck & Co.’s investigational 15-valent pneumococcal conjugate vaccine was “noninferior” to a currently available 13-valent pneumococcal conjugate vaccine in healthy babies 6 to 12 weeks of age.
Pfizer beat Wall Street estimates for Q1 profit and slightly raised the company’s 2019 earnings forecast as the largest U.S. drugmaker reined in costs and recorded higher Ibrance and Prevnar sales.
The U.S. Food and Drug Administration approved ADMA Biologics’ Asceniv to treat primary humoral immunodeficiency disease (PIDD or PI) in adults and adolescents.
