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Tag: fda
FDA approves Novo Nordisk's weight loss injection, Saxenda
2014-12-26 06:37:52| Biotech - Topix.net
Novo Nordisk today announced that the Food and Drug Administration has approved the new drug application for Saxenda , the first once-daily glucagon-like peptide-1 receptor agonist for chronic weight management. Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or who are overweight in the presence of at least one weight-related comorbid condition.
Tags: loss
weight
novo
injection
NxStage Bagged FDA Clearance For System One For Nocturnal Hemodialysis
2014-12-25 22:17:40| Biotech - Topix.net
The company is preparing to launch System One in the U.S. in support of the expanded indication in 2015. NxStage Medical recently announced that its System One portable home-based hemodialysis system has been approved by the FDA for performing overnight hemodialysis, specifically known as nocturnal home hemodialysis .
Tags: system
clearance
fda
nocturnal
FDA clears Novo Nordisk's weight loss drug Saxenda
2014-12-23 23:59:36| Biotech - Topix.net
The Food and Drug Administration has approved a Novo Nordisk diabetes drug as a treatment for obesity. It's the first injectable drug approved for weight loss.
FDA approves new melanoma drug from Bristol-Myers
2014-12-22 23:54:34| Biotech - Topix.net
" The Food and Drug Administration granted accelerated approval Monday to a new drug from Bristol-Myers Squibb to treat the deadliest form of skin cancer. The agency approved Opdivo for patients with hard-to-treat melanoma that cannot be removed via surgery or has spread throughout the body.
Tags: drug
fda
approves
melanoma
FDA OKs Cubist antibiotic for serious infections
2014-12-20 02:18:07| Biotech - Topix.net
The Food and Drug Administration has approved a new combination medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved this year. The approval of Zerbaxa is the second antibiotic approval this year for Cubist Pharmaceuticals, which agreed earlier this month to be acquired for $8.4 billion by the world's fourth-biggest drug maker, Merck & Co.
Tags: infections
fda
antibiotic
oks
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