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...
The U.S. Food and Drug Administration (FDA) has accepted Enochian BioSciences Pre-IND (Investigational New Drug) request for a potential cure of Hepatitis B (HBV). HBV is a viral infection that affects the liver. The request comes after promising results from a...
The U.S. Food and Drug Administration (FDA) has awarded Anivive, a pet health tech company, a $500,000 USD grant to continue research on LAVERDIA™ -CA1 (verdinexor) and its effect on treating canine cancer. As one of four companies selected for the MUMS grant,...
On our most recent Coffee & Conversations podcast episode, podcast hosts Brigid and Shelby joined CSOFT’s President and CEO Shunee Yee and Professor Victoria Elegant, who serves as Vice-President of JAPAC Regional Medical Head of Amgen to discuss The Next...
A drug by AstraZeneca and Amgen designed to treat asthma has been granted a speedy review by the Food and Drug Administration (FDA). The experimental drug tezepelumab aims to reduce asthma attacks for patients with severe and uncontrolled forms of asthma. Both...
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