BioVersys AG received FDA approval to enroll U.S. patients in a global Phase 3 trial evaluating BV100 for hospital-acquired pneumonia caused by carbapenem-resistant Acinetobacter baumannii, with trial completion expected by end of 2027.
The FDA has granted breakthrough device designation to two rapid diagnostic assays from NG Biotech and Hardy Diagnostics targeting Candida auris and carbapenem-resistant Acinetobacter baumannii, both identified as global health priorities by the WHO.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05002582 |
Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs in Patients With Hematological Diseases in China |
UNKNOWN |
