Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Celyad, Deciphera, Fosun, IMV, Inflazome, Janssen, Vanda, Verrica.
Electrocore Inc. has snagged an emergency use authorization (EUA) from the U.S. FDA for use of its Gammacore Sapphire CV noninvasive vagus nerve stimulation (nVNS) to acutely treat asthma exacerbations in known or suspected COVID-19 patients. The hand-held therapy can be used at home and in a health care setting.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Biontech, Clinigen, Cytodyn, Enzychem, Pfizer, Protokinetix.
Infervision Technology Co. Ltd. has received the green light from the U.S. FDA for its Inferread Lung CT.AI product. The artificial intelligence- and deep learning-based technology automatically performs lung segmentation and identifies and labels different types of lung nodules. According to the 510(k) notification, Inferread Lung CT.AI “is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Infervision.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Ipsen.
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