Category: Acad, Gov/Utilities
GE Healthcare Completes Portfolio of Macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) with U.S. FDA Approval of Clariscan in 5mL Glass Vials
The U.S. FDA has approved 5mL glass vial packaging for Clariscan (gadoterate meglumine), completing its packaging portfolio. Clariscan is now approved for patients aged two years and under, making the 5mL vials an efficient option for helping to minimize potential contrast wastage with pediatric patients. Clariscan has been approved in more than 70 countries globally,... Read more
Roche announces FDA approval of Gavreto (pralsetinib) for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers
Basel, 2 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy,... Read more
Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies
Basel, 2 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the... Read more
FDA approves Xolair® (omalizumab) for adults with nasal polyps
Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation Xolair is now FDA-approved across three diseases and in two formulations, continuing to build on the medicine’s 17 years of patient experience since its initial approval for allergic asthma Basel, 01 December... Read more
GE Healthcare Announces U.S. FDA approval of macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) in Pre-Filled Syringes
U.S. FDA approves pre-filled syringe packaging for the macrocyclic gadolinium-based contrast agent, Clariscan™ (gadoterate meglumine). Clariscan has been approved in more than 70 countries globally, with more than seven million patient doses shipped, and now offers a wider range of packaging http://www.ge.com/news/press-releases/ge-healthcare-announces-us-fda-approval-of-macrocyclic-mri-contrast-agent Read more
Microscopy at the MRC-University of Glasgow Centre for Virus Research
Meet four scientists using different types of light microscopy for virology research The MRC-University of Glasgow Centre for Virus Research (CVR) was established in 2010 and represents the UK’s largest grouping of human and veterinary virologists. The CVR is embedded within the Institute of Infection, Immunity and Inflammation at the University of Glasgow, which provides... Read more
Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person
Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person (post-exposure prophylaxis) Roche also provides an update on the sNDA filing for Xofluza in the paediatric setting Basel, 24 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food... Read more
Bringing Ultra-High Field MR Imaging from Research to Clinical: SIGNA 7.0T FDA Cleared
Waukesha, WI – November 10, 2020 – GE Healthcare today announced U.S. FDA 510(k) clearance of SIGNA 7.0T magnetic resonance imaging (MRI) scanner, the world’s most powerful FDA-cleared MRI device available. With a magnet approximately five times more powerful than most clinical systems, SIGNA 7.0T https://www.ge.com/news/press-releases/bringing-ultra-high-field-mr-imaging-from-research-to-clinical-signa-70t-fda-cleared Read more