Legend Biotech: CARVYKTI™ to Treat Multiple Myeloma
Legend Biotech Corporation (Legend Biotech) announced that the U.S. Food and Drug Administration (FDA) has approved its first product, CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel), to treat adult patients with relapsed or refractory multiple myeloma (RRMM) who...
Medtronic Launches NuVent™ Eustachian Tube Dilation Balloon
Medtronic plc has announced the launch of the NuVent™ Eustachian tube dilation balloon, which has been cleared by the U.S. Food and Drug Administration (FDA) for treating chronic, obstructive Eustachian Tube Dysfunction. The NuVent™ balloon serves as an alternative...
FDA Clears Viz.ai’s Cerebral Aneurysm Detection Module
Viz.ai has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz ANEURYSM, a new algorithm that uses artificial intelligence (AI) to detect suspected cerebral aneurysms. The intention is to ensure that patients receive...
FDA Breakthrough Device Designation for Epilepsy Treatment
Precisis GmbH has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Epicranial Application of Stimulation Electrodes for Epilepsy (EASEE) brain stimulator to treat epilepsy. EASEE is a system for individualized brain...
FDA Clearance: LBPs to Treat Parkinson’s Disease
4D pharma plc announced that the FDA has cleared IND applications for two Live Biotherapeutics (LBPs), MRx0005 and MRx0029, for the treatment of Parkinson’s disease. Parkinson’s disease, which impacts more than 10 million people worldwide, is a progressive...
Swissmedic Approval: BeiGene’s BRUKINSA to Treat WM
BeiGene has announced their Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA (zanubrutinib) has been approved by Swissmedic to treat adult patients with Waldenström’s macroglobulinemia (WM). WM is a rare B-cell lymphoma that is primarily found in bone marrow and...
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