GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA dry powder ...
Tags: Asthma Treatment, Medicine
Hospira, a provider of injectable drugs and infusion technologies, has announced the launch of the Sapphire infusion system in the US following regulatory approval from the US Food and Drug Administration (FDA). The Sapphire features an ...
Tags: ambulatory pumps, Hospira
Eli Lilly and Company has received priority review status from the US Food and Drug Administration (FDA) for its ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial ...
Tags: Cancer Drug, FDA Priority
Argentum Medical, a manufacturer of metallic silver based antimicrobial wound dressings, has secured a contract from Biomedical Advanced Research and Development Authority (BARDA). As per the contract, the company will perform studies for ...
Tags: Argentum Medical, Medicine
Cardiovascular Systems, a US-based medical device company, has obtained a premarket approval from the US Food and Drug Administration (FDA) for its Diamondback 360 coronary orbital atherectomy system (OAS), designed to treat severely ...
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