Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyalex Orthopaedics, Inmode, Neuraxis, Stryker.
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Appili, Cordis, Gradient Denervation, ITM Isotop, Radiopharm.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Trax Surgical.
Regeneron Pharmaceuticals Inc. was the successful bidder for 23andme Holding Co.’s personal genome service, total health and research services business lines, including its biobank and associated assets, in the bankruptcy auction to sell 23andme's assets.
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