FDA Approvals - Diagnostic HYBRIDS Receives FDA Clearance For D3 DFA Metapneumovirus Identification
Diagnostic HYBRIDS Receives FDA Clearance For D3 DFA Metapneumovirus Identification Kit (Medical News Today)
Diagnostic HYBRIDS announces the release of its D3 DFA Metapneumovirus Identification Kit for the U.S. market. The kit is the only FDA-cleared device that detects and identifies human metapneumovirus (MPV) from nasal and nasopharyngeal swabs, aspirates and washes using patent-pending MPV monoclonal antibodies.
Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward To Resume Oxycyte Clinical Trials In TBI ... (Medical News Today)
Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) announced that the company has received a letter from the FDA that outlines what the agency termed a "path forward" as a basis to resume clinical studies of Oxycyte(R) in TBI. Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier.
FDA Advisory Committee Finds Favorable Risk-Benefit Profile For Oral Anticoagulant Rivaroxaban For Prophylaxis Of Deep ... (Medical News Today)
Ortho-McNeil announced that the U.S. Food and Drug Administration's (FDA's) Cardiovascular and Renal Drugs Advisory Committee has determined that rivaroxaban, a novel, investigational, oral anticoagulant, has a favorable risk-benefit profile for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip replacement or knee replacement surgery.