DiFusion Technologies has received the US Food and Drug Administration's (FDA) approval for its Vestakeep Peek-based Xiphos ALIF (polyetheretherketone) spinal implant for use in Interbody Fusion (IBF) devices. Evonik's Vestakeep Peek is ...
The United States Food and Drug Administration (FDA) has accepted Invacare's first certification audit relating to the qualification and validation documentation for equipment and processes at the Taylor Street manufacturing facility in ...
Sorin Group, a Netherlands-based company, has received US FDA approval for the launch the Smartview remote monitoring solution for patients with implanted cardiac rhythm management (CRM) devices. Using the secure SMARTVIEW remote ...
Tags: Sorin Group, Monitoring Solution
GlaxoSmithKline (GSK) and Theravance have announced the FDA approval of Breo Ellipta as maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD) patients. The inhaled long-term, once-daily maintenance ...
Tags: GSK, Theravance, Copd Therapy
Warner Chilcott has announced US FDA approval of norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets, new oral contraceptive. The company expects to make the product available in early August 2013. ...
US-based Life Spine has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for its IRIS Anterior Cervical Plate System (ACPS). The IRIS ACPS comprises a low profile plate with a zero-step integrated nitinol ...
Tags: Life Spine, Plate System
Merck, referred to as MSD outside the US and Canada, has obtained FDA approval for Liptruzet tablets as an adjunctive therapy to diet for the treatment of elevated low-density lipoprotein (LDL) cholesterol in primary or mixed hyperlipidemia ...
Tags: Merck, Liptruzet Tablets
The US Food and Drug Administration (FDA) has approved Raptor's Procysbi (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children six years and older. Studies have shown that ...
Tags: Capsules, Raptor's Procysbi
Respicardia, a US-based implantable therapies developer, has received approval from the US Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) to begin the pivotal trial of remedē System. The trial will ...
Tags: Respicardia, therapies developer
GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the US FDA for umeclidinium bromide (UMEC) monotherapy 62.5mcg to treat chronic obstructive pulmonary disease (COPD). The investigational once-daily UMEC, administered ...
Tags: GlaxoSmithKline, FDA Approval, chronic obstructive pulmonary disease
BioFire Diagnostics has submitted 510(k) Application to the US Food and Drug Administration (FDA) for its FilmArray Blood Culture Identification (BCID) Panel. The BCID panel provides automatic results for the most common infectious causes ...
Tags: Biofire, Filmarray Blood Culture
Medtronic has enrolled the first patients in a blinded, controlled, multicenter, parallel arm SubQStim II study of its peripheral nerve stimulation (PNS). Delivered to patients using the company's neurostimulation system, PNS is designed ...
The Food and Drug Administration (FDA) has approved Duchesnay USA's Diclegis delayed-release tablet for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. The FDA granted ...
Tags: FDA, Duchesnayusa's Diclegis
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application for Vancomycin hydrochloride capsules, USP, 125mg and 250mg. The company has begun the shipment of the product ...
Neuralstem has obtained notice of allowance for a patent that covers various methods to use expanded spinal cord stem cells such as NSI-566 to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The company completed Phase ...