News Related to Multiple Myeloma Criteria (CRAB)

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FDA Approves BioVersys Phase 3 Trial for Drug-Resistant Pneumonia Treatment

Mar 16, 2026

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.

FDA Grants Breakthrough Device Status to Rapid Tests for Drug-Resistant Pathogens

Feb 28, 2026

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.