FDA Clears PICO Systems for Closed Surgical Incisions to Reduce Wound Complications
The clearance was based on data from 25 clinical studies which included 5560 patients.
Bacterial Infections
Microbiome Therapeutic Beats Placebo for Recurrent C. difficile
Investigational oral live microbiome therapeutic superior to placebo in patients with three or more episodes of C. difficile infection
Shorter Antibiotic Course Safe, Effective for Uncomplicated Childhood CAP
The randomized, double-blind, placebo-controlled study included a total of 380 patients aged 6 to 71 months with nonsevere CAP.
Fosfomycin Not Noninferior to Comparators for Bacteremic UTI
Fosfomycin not noninferior to ceftriaxone or meropenem for bacteremic urinary tract infection due to multidrug-resistant E. coli in adults
New Drugs Approved in 2021
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
Tebipenem HBr Gets Priority Review for Oral Treatment of Complicated UTI
The application includes data from the phase 3 ADAPT-PO trial, which evaluated the efficacy and safety of tebipenem HBr in 868 adults with cUTI or acute pyelonephritis.
HHS Carcinogen Report Updated to Include 8 Substances
The US Department of HHS added 8 new substances to the 15th Report on Carcinogens, bringing the total list to 256 substances.
IDSA Issues Guidance on Treating Antimicrobial-Resistant Infections
Guidance focuses on AmpC β-lactamase-producing Enterobacterales, carbapenem-resistant A. baumannii, S. maltophilia infections
Xaciato Vaginal Gel Approved for Bacterial Vaginosis
Xaciato, a lincosamide antibacterial, is a thermosetting bioadhesive hydrogel containing clindamycin phosphate 2%.
Xenleta Now Available in New Oral Pack for Community-Acquired Bacterial Pneumonia
The new 10-count packaging provides convenience for patients and health care professionals with a complete 5-day course of treatment.
