US-based pharmaceutical firm Merck has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational oral combination regimen MK-5172/MK-8742 for the treatment of chronic hepatitis C virus ...
US-based iCeutica announced that its partner Iroko Pharmaceuticals has received the US Food and Drug Administration (FDA) approval to market ZORVOLEX (diclofenac) capsules, a non-steroidal anti-inflammatory drug (NSAID) that utilizes ...
Medical technology company Medtronic has introduced the Export Advance aspiration catheter, a new device to remove coronary thrombus, in the US. Export Advance aspiration catheter has a pre-loaded stylet, which increases the ...
Tags: Medtronic, Aspiration Catheter
Bayer HealthCare has announced that the US Food and Drug Administration (FDA) has cleared its CONTOUR next link blood glucose monitoring (BGM) system as a component of Medtronic's new MiniMed 530G with Enlite, a breakthrough diabetes ...
Tags: Bayer HealthCare, Medicine
US-based Integra LifeSciences has announced the launch of Licox brain tissue oxygen monitoring system, which continually monitors brain oxygen partial pressure (PtO2) in patients who have sustained a traumatic brain injury or cerebral ...
Tags: Oxygen Monitoring System, Medicine
Biomet, a manufacturer of orthopedic and biotechnology products, has announced the first US implantation of its Comprehensive nano stemless shoulder as part of an US Food and Drug Administration investigational device exemption (IDE) ...
Tags: Biomet, Nano Stemless Shoulder
Medical device company Varian Medical Systems has obtained 510(k) approval from the US Food and Drug Administration for RapidPlan, a radiotherapy treatment planning tool designed to enhance quality, consistency, and efficiency in ...
GlaxoSmithKline (GSK) and Danish biotechnology firm Genmab have filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the use of its leukaemia drug Arzerra (ofatumumab) in combination ...
Tags: GlaxoSmithKline, CLL Patients
Foundation Medicine, molecular information company, has announced that results from a 24-month, multi-institution collaboration demonstrating the analytic validation of its cancer genomic profiling assay, FoundationOne, were published in ...
Tags: Foundation Medicine
Pfizer has secured European Commission approval to carry out updates to the summary of product characteristics (SmPC) for its pneumococcal conjugate vaccine (PCV) Prevenar 13, regarding its use in certain high-risk populations. Now the ...
Tags: Pfizer, Label Update
Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that a patent has been issued by the US Patent and Trademark Office (USPTO) covering its Oxycodone DETERx formulation. Additionally, an application has been ...
Using LED light sources as a medium for light therapy devices can stimulate the human body’s metabolism rate and greatly reduce medical risks associated to conventional light therapy, such as laser and intense pulse light, said Simon ...
Tags: LED Light, Lower Treatment Risks
AGC Chemicals, a subsidiary of Asahi Glass, has introduced the new AG-E070 to its line of AsahiGuard E-SERIES fluoropolymers for sizing in food contact paper, paperboard and pulp molding applications. The product has been designed to ...
Tags: AGC Chemicals, Food Contact Paper
CardioFocus, developer of the HeartLight endoscopic ablation system (EAS) for the treatment of atrial fibrillation (AF), has concluded enrollment of its US pivotal trial evaluating the HeartLight system, for the treatment of symptomatic ...
Amarin, a biopharmaceutical company, has announced the outcome of the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee for the use of Vascepa (icosapent ethyl) capsules in the treatment of high ...