Lea Eslava-Kim

PharmD

Most Recent Articles by Lea Eslava-Kim

Oral Prophylactic Therapy Designated Breakthrough Therapy for CDI Prevention

Oral Prophylactic Therapy Designated Breakthrough Therapy for CDI Prevention

By

The FDA granted Breakthrough Therapy designation to Synthetic Biologics' ribaxamase SYN-004 for Clostridium difficile infection prevention.

Injectable Antibiotic Promising for Treatment of Complicated UTIs

Injectable Antibiotic Promising for Treatment of Complicated UTIs

By

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

Treatment of CAP: Phase 3 Results of Novel Tetracycline

By

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

FDA: QDIP Status for Post-Surgical Sternal Infection Antibiotic Reservoir

By

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

Plague Vaccine Granted Orphan Drug Designation

By

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.

More Articles by Lea Eslava-Kim

Sign Up for Free e-newsletters