Oral Prophylactic Therapy Designated Breakthrough Therapy for CDI Prevention
The FDA granted Breakthrough Therapy designation to Synthetic Biologics’ ribaxamase SYN-004 for Clostridium difficile infection prevention.
The FDA granted Breakthrough Therapy designation to Synthetic Biologics’ ribaxamase SYN-004 for Clostridium difficile infection prevention.
Zolyd (fosfomycin for injection) was found to be safe and generally well-tolerated, mostly with mild and transient treatment emergent adverse events reported.
Paratek announced positive outcomes for their phase 3 trial of omadacycline for treating community-acquired bacterial pneumonia.
The FDA has granted Qualified Infectious Disease Product (QIDP) to D-PLEX (Doxycycline/Polymer-Lipid Encapsulation Matrix; PolyPid), a secured antibiotic drug reservoir for the local prevention and treatment of surgical infections.
FDA has granted Orphan Drug designation to the recombinant rF1V plague vaccine for pre-exposure prophylaxis of Yersinia pestis infection, also known as, the plague.
Novel antibiotic, cefiderocol (S-649266) shows promise for the treatment of patients with complicated UTI by Gram-negative bacteria.