je.st
news
Tag: fda
Hansa Medical receives FDA Orphan Drug Designation for IdeS
2015-09-15 06:06:51| Appliances - Topix.net
Hansa Medical today announced that the U.S. Food and Drug Administration has granted orphan drug designation to IdeS for the prevention of antibody mediated organ rejection in solid organ transplant patients. More information about the ODD has been posted on www.fda.com Approximately 30 percent of the patients on the waiting lists for kidney, heart, lung and pancreas, equivalent to approximately 35 000 patients in the US, are sensitized to Human Leukocyte Antigen .
Tags: medical
drug
receives
designation
Philips Receives FDA 510(k) Clearance for Spectral Diagnostic Suite
2015-09-14 12:31:15| Industrial Newsroom - All News for Today
On-demand visualization and analytics solution for Philips IQon Spectral CT delivers expanded clinical applications and drives diagnostic confidence ANDOVER, Mass. - Reinforcing its commitment to improving diagnostic confidence through innovation, Royal Philips (NYSE: PHG AEX: PHIA) today announced that it has...
Tags: suite
philips
clearance
receives
Amgen seeks FDA approval for monthly dosing option for Repatha
2015-09-11 17:48:27| Biotech - Topix.net
Amgen Inc said it had asked the U.S. Food and Drug Administration to approve a monthly single-dosing option for its recently approved cholesterol drug, Repatha. The FDA approved Repatha, one of two approved treatments in a new class of injectable "bad" cholesterol-lowering drugs called PCSK9 inhibitors, on Aug. 27. The drug is approved for patients with hereditary forms of high cholesterol - heterozygous familial hypercholesterolemia and a rarer homozygous form of the condition, in addition to those with cardiovascular disease.
Tags: option
monthly
approval
seeks
FDA Guidance for Products from Tianjin, CN
2015-09-11 10:00:00| Expeditors Newsflash - Americas Edition
Expeditors Newsflash - Americas Edition
Tags: products
guidance
fda
tianjin
GMA Welcomes FDA Release Of Final FSMA Regulations
2015-09-11 05:28:14| foodingredientsonline News Articles
The Grocery Manufacturers Association (GMA) issued the following statement from Pamela G. Bailey, president and CEO, on the U.S. Food & Drug Administration’s (FDA) release of the final regulations for the Food Safety Modernization Act (FSMA)
Tags: final
release
regulations
welcomes
Sites : [75] [76] [77] [78] [79] [80] [81] [82] [83] [84] [85] [86] [87] [88] [89] [90] [91] [92] [93] [94] next »