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.
All articles by Lea Eslava-Kim
Injectable Antibiotic Promising for Treatment of Complicated UTIs
Zolyd (fosfomycin for injection) was found to be safe and generally well-tolerated, mostly with mild and transient treatment emergent adverse events reported.
Treatment of CAP: Phase 3 Results of Novel Tetracycline
Paratek announced positive outcomes for their phase 3 trial of omadacycline for treating community-acquired bacterial pneumonia.
FDA: QDIP Status for Post-Surgical Sternal Infection Antibiotic Reservoir
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.
Plague Vaccine Granted Orphan Drug Designation
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 Shows Promise in Treating Complicated UTI
Novel antibiotic, cefiderocol (S-649266) shows promise for the treatment of patients with complicated UTI by Gram-negative bacteria.
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