US Food and Drug Administration (FDA)
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DeepTek.ai secures US FDA clearance for chest X-ray AI solution
DeepTek’s Chest X-ray AI covers the entire chest area, offering analysis for a broad range of lung, pleural, cardiac pathologies…
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FDA approves Roche’s Lunsumio to treat people with relapsed or refractory follicular lymphoma
Lunsumio is administered as an intravenous infusion for a fixed duration, which allows for time off therapy, and can be…
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SonoScape receives FDA 510(k) clearance for HD-550 Endoscopy system
Paired with a 4-LED light source, which supports 1080P high definition, the HD-550 endoscopy system enables multi-spectrum and multi-mode SonoScape…
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Velico Medical achieves milestones in developing spray-dried plasma for point-of-care transfusions
Receives US FDA approval to proceed with a Phase-I (human) clinical study for its proprietary FrontlineODP system for spray drying…
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Biocon Biologics, Viatris receive US FDA nod for Semglee
Semglee is used in the treatment of diabetes Biocon Biologics and Viatris announced that the US Food and Drug Administration…
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iSTAR Medical to start trial for MINIject in glaucoma patients
Bags US FDA approval iSTAR Medical, a med-tech company developing minimally-invasive implants for glaucoma surgery (MIGS), announced that the US…
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Thermo Fisher Scientific’s Amplitude Solution receives FDA nod for COVID-19 testing
The modular solution processes samples in a four-step process requiring minimum hands-on time, laboratory space and staffing resources Thermo Fisher…
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FDA delays decision on Bristol Myers cancer therapy
Coronavirus-related travel restrictions is the reason for the delay Bristol Myers Squibb said that the US health regulator has deferred…
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Lupin announces FDA filing acceptance of supplemental drug application for Solosec
The drug if approved could be the only single-dose oral prescription treatment for both BV and trichomoniasis Lupin Pharmaceuticals, the…
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XNK Therapeutics receives US orphan drug status
The status was received for NK cell-based immunotherapy in multiple myeloma XNK Therapeutics has received Orphan Drug Designation (ODD) from…
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