AstraZeneca has been granted FDA approval for its once-weekly diabetes medicine Bydureon (exenatide) to treat children (aged 10-18) with type-2 diabetes. The drug, an injectable suspension, aims to lower blood sugar rates. The approval is based on a late-stage study...
Our LATAM series continues this week with Mexico’s medical device regulatory pathway. In 2019, Mexico’s import medical device market was estimated to be approximately $5.7 billion USD. In 2020, that number increased to $6.5 billion USD. With demand for medical devices...
Merck (also known as MSD outside of North America) and Eisai Inc. announced that the FDA (Food and Drug Administration) has given approval for the combined treatment of Merck’s KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, and Elsai’s LENVIMA (lenvatinib), a...
The FDA (Food and Drug Administration) has given Octapharma USA approval for the first-ever intravenous immunoglobulin, called Octagam 10%, to treat adult dermatomyositis. 10 out of every million people in the US live with Dermatomyositis, a rare, idiopathic...
The US FDA (Food and Drug Administration) plans to modify labelling on all statins to change the blanketed contraindication on the drugs in all pregnant patients. Statins, a group of lipid-lowering drugs, are used to help reduce illness and mortality of patients who...
Johnson & Johnson is recalling Neutrogena Beach Defense and Ultra Sheer sunscreens after elevated levels of benzene were detected. Benzene is a chemical compound that, over long term and frequent exposure via skin contact or inhalation, can cause serious health...
Ipsen, a global pharma company, and IRLAB, a Swedish research and development business, have entered an exclusive licensing agreement for Ipsen to commercialize mesdopetam, a dopamine D-3 receptor antagonist taken orally to improve the quality of life for patients...
The U.S. Food and Drug Administration (FDA) has granted iSTAR Investigational Device Exemption (IDE) approval for to begin a trial with MINIject, a revolutionary MIGS device for patients with primary open-angle glaucoma. The study will test the safety and efficacy of...
The Medical Device Coordination Group (MDCG), part of the European Commission, has provided a guidance document navigating the use of codes under the In Vitro Diagnostic Regulation (IVDR). The codes are used to describe the qualifications of both the notified body...
The U.S. Food and Drug Administration (FDA) has cleared the first ever biodegradable subacromial balloon spacer developed by OrthoSpace Inc. and acquired by Stryker. The balloon, called InSpace, is the first implant for arthroscopic treatment of MIRCTs (massive...
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