je.st
news
Tag: fda
FDA panel backs Glaxo inhaler for adults, not adolescents
2015-03-20 02:54:36| Biotech - Topix.net
The Food and Drug Administration panel of experts voted 18-2 against using the British drugmaker's Breo Ellipta in asthma patients ages 12 to 17. That followed a positive vote of 16-4 supporting the drug's use in asthma patients 18 and up. Breo Ellipta is already approved in the U.S. for a type of chronic lung disease, but Glaxo is hoping to expand the drug's use to the much larger patient population of roughly 37 million Americans with asthma.
Tags: panel
adults
backs
adolescents
FDA, EPA To Share Data
2015-03-17 09:00:00| Happi Breaking News
Memorandum of Understanding covers pesticides and toxic substances.
PointCross Announces SEND-ASSURE for Data Consistency in Submissions to the FDA
2015-03-16 11:31:15| Industrial Newsroom - All News for Today
SEND-ASSURE is an audit solution to reduce risks in Regulatory e-Data Submissions SILVER SPRING, Md., PointCross Life Sciences today announced the launch of its SEND-ASSURE audit solution to help pharmaceutical companies avoid the consequences of submitting standardized nonclinical data that is inconsistent with...
Tags: the
data
submissions
announces
FDA, EPA To Share Data
2015-03-16 06:00:00| Happi Breaking News
Memorandum of Understanding covers pesticides and toxic substances.
FDA Decision Signals New Competition For Some Of The Costliest Drugs
2015-03-10 22:49:57| Biotech - Topix.net
McCamish is in charge of biopharmaceutical drug development at the Sandoz division of Switzerland's Novartis. He and his colleagues made the case to a panel of 14 cancer specialists and a group of Food and Drug Administration regulators that a company drug codenamed EP2006 should be approved for sale in the U.S. The drug, brand name Zarxio, is similar to but not quite identical to Amgen's Neupogen, a medicine approved by the FDA back in 1991 to fight infections in cancer patients.
Tags: the
decision
competition
drugs
Sites : [103] [104] [105] [106] [107] [108] [109] [110] [111] [112] [113] [114] [115] [116] [117] [118] [119] [120] [121] [122] next »