Johnson & Johnson MedTech receives IDE approval for Ottava system
Johnson & Johnson MedTech announced that the U.S. Food & Drug Administration has approved the Ottava robotic surgical system ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
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Autolus Therapeutics Gains FDA Approval for AUCATZYL®
Autolus Therapeutics ( (AUTL)) has provided an update. Autolus Therapeutics plc has achieved FDA approval for AUCATZYL®, a treatment for relapsed and refractory B-cell acute lymphoblastic leukemia, ...
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Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial
mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus ...
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FDA approves new CAR-T competitor to Gilead’s Tecartus
Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the ...
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Nordic Bioscience Gets FDA Letter of Support for CPa9-HNE Biomarker in IBD
The biomarker assay can be used potentially to enrich clinical trials and monitor patients' disease activity and treatment response.
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Syncona’s Autolus Gains FDA Approval for Leukemia Therapy
Syncona Shs GBP (GB:SYNC) has released an update. Syncona’s portfolio company, Autolus Therapeutics, has received FDA approval for AUCATZYL®, a ...
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Histomonosis transmission insights could improve treatment
There are currently no approved treatments to prevent, treat or control histomonosis, also known as blackhead disease or ...