The US Food and Drug Administration (FDA) has cleared Omeros' investigational new drug application (IND) for OMS824 in Huntington's disease. OMS824 is developed to selectively inhibit phosphodiesterase 10 enzyme that is expressed in areas ...
Tags: Omeros'IND, Medicine
US Food and Drug Administration intends to have tighter rules for apps that allow to diagnose or treat medical conditions, similar to the 2011 proposal urging for quality standards for ultrasound machines, heart stents, and several other ...
Tags: Stringent Rules, Medical Apps
Chilled food manufacturer Greencore will continue to benefit from the long-term trend towards convenience food but, in the UK, the horsemeat scandal is continuing to depress its performance. Patrick Coveney predicted adjusted earnings per ...
Tags: Greencore, Convenience Food
Covidien has announced that its Nellcor pulse oximetry portfolio received the US Food and Drug Administration (FDA) 510(k) clearance for motion claims. The Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen ...
Tags: Covidien, Motion Claims
Ashland Performance Materials will introduce its flexible food packaging adhesives at the upcoming ChinaPlas in Guangzhou, China, Asia's International Plastics and Rubber Trade Fair taking place from 20 – 23 May 2013. The company ...
Tags: Ashland, Food Packaging Adhesives
US food company Campbell Soup has reported that its net earnings increased 2.2% for the third quarter of 2013 to $181m, compared with $177m for the same period in 2012, due to double-digit sales growth in condensed, ready-to-serve soups and ...
Tags: Campbell, food company
The US Food and Drug Administration (FDA) has approved the use of diagnostics provider Hologic's new C-View 2D imaging software. C-View 2D images can now be used in place of the conventional 2D exposure previously required as part of a ...
Tags: 2D Imaging Software, Medicine
The US Food and Drug Administration (FDA) has cleared Oramed's investigational new drug (IND) application for ORMD-0801, an oral insulin capsule, allowing the company to begin clinical trials of the drug. ORMD-0801 is an orally ingestible ...
Tags: FDA, Oral Insulin Capsule
Mylan Pharmaceuticals, the subsidiary of Mylan, has introduced Fenofibrate tablets, 48 mg and 145 mg. The company has received the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application ...
Tags: Mylan, Generic Version
Eco-Cuisine, an establishment based in Boulder, Colorado, US, is recalling all lots of baking mix products as they have the potential to be contaminated with Salmonella. The recall was initiated as a result of notification by CHS Foods ...
Tags: Eco-Cuisine, Baking Mix Products
Health Canada has approved Life Technologies' applied biosystems 3500 Dx /3500 xL Dx Genetic Analyzers CS2 for diagnostic use. The 3500xL Dx is an automated 24 capillary Sanger Sequencer instrument while the 3500 Dx is an eight capillary ...
Tags: Health Canada, Genetic Analyzers
EnteroMedics is planning to submit the pre-PMA (Premarket Approval) application for its Maestro Rechargeable System's VBLOC vagal blocking therapy, based on the ReCharge Pivotal Trial, in the second quarter of 2013. The decision follows ...
Tags: Enteromedics, VBLOC Therapy
The US Food and Drug Administration (FDA) has approved Thoratec's HeartMate II Pocket Controller, the safe face of the HeartMate II LVAD System. The Pocket Controller is lighter and compact than the previous LVAD system controllers, and ...
Dental lasers distributor Biolase has announced that the US Food and Drug Administration (FDA) has cleared NewTom Biolase VG3 digital panoramic, cephalometric, and tomographic extra-oral X-ray system. The VG3 is a complement to the ...
Tags: FDA, Panoramic Oral X-Ray System
Roche Group member Genentech and Astellas Pharma US announced that the US Food and Drug Administration (FDA) has cleared Tarceva (erlotinib). The tablets are used for the initial treatment of people with metastatic non-small cell lung ...
Tags: FDA, Tarceva Tablets, Astellas Pharma