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Nectero Medical Receives FDA Fast Track Designation for Nectero EAST® System

Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease, announced that the U.S. Food and Drug Administration (FDA) has granted...

CVS Health Launches Cordavis

CVS Health®, announced that it has launched Cordavis, a wholly owned subsidiary that will work directly with manufacturers to commercialize and/or co-produce biosimilar products (an...

Welldoc Receives 11th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®

Welldoc®, a digital health leader revolutionizing chronic care, announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its...

Artiva Biotherapeutics Announces FDA Clearance of IND for AlloNK® Cell Therapy Candidate in Combination with Rituximab in Lupus Nephritis

Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced that the...

FDA Grants Breakthrough Device Designation To Tempus’ HLA-LOH Companion Diagnostic Test

Tempus, a leader in artificial intelligence and precision medicine, announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough Device...
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