I-Mab has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its novel Claudin 18.2 x 4-1BB bispecific antibody, TJ-CD4B, to treat gastric cancer, including cancer of gastroesophageal junction. TJ-CD4B is the first...
Valencia Technologies announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin® tibial neurostimulator to treat urinary urge incontinence (UUI). UUI, affecting over 60% of patients who suffer from Overactive Bladder...
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...
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...
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...
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...
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