Boston Scientific has implanted the first patient with a new version of its Ingevity pacing leads, designed for use in the magnetic resonance imaging (MRI) environment, in a clinical study. The pacing leads, which are expected be paired ...
GlaxoSmithKline (GSK) and Theravance have submitted a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, umeclidinium bromide (UMEC/VI), to treat chronic obstructive pulmonary disease (COPD) ...
Tags: GlaxoSmithKline, regulatory application, Medicine, FDA
Aurobindo Pharma has won the final FDA approval to manufacture and market its generic anti-Human Immunodeficiency Virus (HIV) drug, Abacavir Tablets USP 300mg. Abacavir, the generic version of ViiV Healthcare Company's Ziagen Tablets ...
Tags: Anti-HIV Drug, FDA Nod, Aurobindo, Medicine
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Quinine Sulfate Capsules USP, 324mg, the generic equivalent to Mutual Pharmaceutical's Qualaquin. Mylan has commenced shipping the generic ...
Tags: FDA, Capsules Anda, Mylan Pharmaceutical, Medicine
Ironwood Pharmaceuticals and Forest Laboratories have announced the availability of guanylate cyclase-C (GC-C) agonist, Linzess across the US pharmacies. The FDA approved, once-daily, oral product is indicated for adults with irritable ...
Tags: FDA, CIC, Ironwood Pharmaceuticals and Forest Laboratories, Medicine
Braeburn, a subsidiary of Apple Tree Partners, has gained commercialization rights to Titan Pharmaceuticals' long-acting subdermal implant in the US and Canada, under the signed license agreement. The investigational subcutaneous implant, ...
Tags: Braeburn, Marketing Rights, subsidiary of Apple Tree Partners, Medicine
The US Food and Drug Administration(FDA)has granted 510(k)clearance to PhysioSonics'cranial blood flow monitoring system. The Presto 1000 Flow Monitor,which uses the company's proprietary Flash Doppler,maintains the flow of information ...
Tags: FDA, PhysioSonics cranial blood flow monitoring system
The National Consumers League(NCL),the nation's oldest consumer advocacy organization founded in 1899 to protect and promote the rights of consumers and workers,has sent a letter to David Sunflower Seeds,a subsidiary of ...
Tags: NCL, Sunflower Seeds, FDA, labels
In August 2012, the world's first MATS microwave food sterilization system was installed at AmeriQual in Evansville, IN. This MATS-B device, designed for recipe and process development, incorporates the only microwave technology accepted by ...
Tags: microwave food, sterilization system, MATS-B, microwave technology
Taylor Farms Retail is recalling 110 cases of Taylor Farms Hearts of Romaine in the US, as the products may be contaminated with Listeria monocytogenes. The recall has been initiated after a single random finished package test by the Food ...
Alere Inc received confirmation that the US Food and Drug Administration (FDA) has cleared the Techlab® Shiga Toxin Quik Chek test for the US market. Shiga Toxin Quik Chek is the only rapid diagnostic available that can detect Shiga ...
Tags: Alere Inc, Techlab, Shiga Toxin Quik Chek, E.coli
In Star Trek: The Motion Picture, the humanoid crew members of the Enterprise wore little boxes near the waistlines of their pajama-like uniforms. While their purpose wasn't explained in the film's dialogue, these were supposed to be ...
Tags: medical telemetry devices, cell phones, computers, Prognosis, medical apps
The US Food and Drug Administration(FDA)has granted 510(k)clearance to Ascendx Spine's minimally invasive Ascendx VCF Repair system,designed for the treatment of vertebral compression fractures(VCFs). The VCF Repair system,unlike the ...
Antares Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Otrexup, a combination product to deliver methotrexate methotrexate (MTX) using Medi-Jet technology. Antares Pharma president ...
Tags: NDA, FDA, medical technology
Insulet has gained the US Food and Drug Administration's (FDA) 510(k) approval for its new version of tubeless insulin pump. The new easy-to-use OmniPod insulin management system features the same 200-unit insulin reservoir capacity, ...
Tags: FDA, Insulet, tubeless insulin pump, clinical technology