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Tag: fda
Elekta Receives US FDA 510(k) Clearance for Its Monaco 5 Treatment Planning System
2013-11-27 06:00:00| Industrial Newsroom - All News for Today
Monaco 5 radiation therapy treatment planning system unites capabilities in a single system<br /> <br /> ATLANTA — Monaco® 5, the latest version of Elekta's Monaco treatment planning system has received 510(k) clearance from the US Food Drug Administration, making it available for purchase and use in the United States.<br /> <br /> "Monaco 5 consolidates the best of Elekta's treatment planning solutions into one system, increasing confidence and clinical versatility for the radiation ...This story is related to the following:Planning Software |
Tags: system
planning
treatment
monaco
FDA Approves Mercks NOXAFIL (posaconazole) Delayed-Release Tablets
2013-11-26 15:00:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL (posaconazole) 100 mg delayed-release tablets. NOXAFIL delayed-release tablets are a new formulation with a loading dose of 300 mg (three 100 mg delayed-release tablets) twice daily on the first day, followed by a once-daily maintenance dose of 300 mg (three 100 mg delayed-release tablets) starting on the second day of therapy. Language: English Contact: MerckMedia Contacts:Pam Eisele, 908-423-5042Robert Consalvo, 908-423-6595orInvestor Contacts:Carol Ferguson, 908-423-4465Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: tablets
fda
approves
fda approves
FDA overturns safety limits on diabetes drug
2013-11-25 23:23:10| Biotech - Topix.net
The repeal means patients will no longer have to enroll in a special registry to be eligible to receive the drug.
Tags: safety
drug
limits
diabetes
FDA loosens restrictions on Avandia
2013-11-25 23:23:09| Biotech - Topix.net
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Tags: restrictions
fda
avandia
loosens
DNAmbiguous: FDA orders 23AndMe to submit its product for evaluation and efficacy testing
2013-11-25 19:23:58| Extremetech
The FDA has yanked its approval of 23andMe's product, giving the company 15 days to produce data that demonstrates the efficacy of its testing or face further penalties.
Tags: product
submit
orders
evaluation
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