The US Food and Drug Administration (FDA) has approved Merck's Noxafil (posaconazole) 100 mg delayed-release tablets. The tablets are a new formulation with a loading dose of 300mg (three 100mg delayed-release tablets) twice daily on the ...
QRxPharma, an Australian-based commercial-stage specialty pharmaceutical company, has resubmitted its MOXDUO new drug application (NDA). At a meeting in early October 2013, the US Food and Drug Administration (FDA) provided QRxPharma with ...
Tags: QRxPharma, Drug Application
A research paper published in the scientific journal Tobacco Control shows that graphic warning labels on cigarette packs led to a decrease in smoking rates in Canada of between 12% and 20% from 2000 to 2009. The authors estimate that if ...
Avalon Laboratories, LLC Avalon will showcase its capabilities to offer feature-rich single piece medical devices not currently available with extrusion technology in booth #204 at BIOMEDevice San Jose. Avalon will showcase its ...
Tags: Avalon, present, polymer, solution casting, technology, feature-rich
Posted in Testing Services by Chris Newmarker on November 25, 2013 The FDA is telling 23andMe to stop marketing its Personal Genomic Service tests. The FDA’s move is but another sign that the regulator is increasingly concerned ...
Tags: 23andMe, DNA, Hit, FDA, warning letter
Silicone materials are widely used in Medical applications since from 60 years. Quickly after their Commercial availability in 1946, methylchlorosilanes were described to treat glassware to prevent blood from clotting. An effort was made by ...
Tags: application, FDA, grade, silicone, tubing
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) first adjuvanted vaccine for the prevention of H5N1 influenza, also known as avian or bird flu. The pandemic Influenza A (H5N1) Virus Monovalent Vaccine, ...
Tags: Bird Flu Vaccine, GlaxoSmithKline
US-based Boston Scientific has obtained an approval from the US Food and Drug Administration (FDA) for its Promus PREMIER everolimus-eluting platinum chromium coronary stent system. The company's next-generation durable polymer ...
CAS Medical Systems, a manufacturer of medical devices for non-invasive patient monitoring, has obtained an approval from the China Food and Drug Administration (FDA) for its FORE-SIGHT cerebral oximeter. CAS Medical Systems claims that ...
Following U.S. Food and Drug Administration actions, USPLabs in Texas recalled and destroyed a supplement linked to liver failure and hepatitis, officials say. "As soon as we suspected a possible link between OxyElite Pro products and ...
One year after more than 60 died and 750 were sickened by fungal meningitis, the U.S. Senate passed a law to help ensure compound drug safety, officials say. The Drug Quality and Security Act reflects a bipartisan, bicameral effort to ...
The U.S. Food and Drug Administration halted the selling of the 23andMe Saliva Collection Kit and Personal Genome Service -- a home DNA test. In a letter posted on its website, the FDA alleged 23andMe was being sold without clearance or ...
After 85 years, antibiotics are growing impotent. So what will medicine, agriculture and everyday life look like if we lose these drugs entirely? A few years ago, I started looking online to fill in chapters of my family history that no ...
Tags: imagining, post-antibiotics, future
The firm sealed a sales agreement with Paper Pak Industries (PPI) on the use of UltraZap XtendaPak absorber for its first use in Europe. The absorber, which is already available in the US, is placed underneath the packaged meat and limits ...
Aerocrine, a medical products company, has announced that Japanese health authorities have approved the use of its FeNO-measuring device NIOX MINO as a tool for assessing patients with airway inflammation such as asthma. On 19 November ...