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Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C

2013-06-09 00:00:05| Biotech - Topix.net

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has granted priority review to the company's New Drug Application for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus infection.

Tags: of review treatment priority

 

FDA panel wants changes to Avandia safety measures

2013-06-07 00:04:54| Biotech - Topix.net

Federal health experts are recommending changes to safety restrictions on former blockbuster diabetes pill Avandia, in light of a new analysis suggesting that the drug may not increase the risk of heart attack as previously believed.

Tags: safety panel measures fda

 
 

FDA plan for menu labels too costly, Kroger argues

2013-06-06 07:38:19| Grocery - Topix.net

Grocers around the country, though - including Cincinnati-based Kroger Co. - are trying to persuade the federal Food and Drug Administration to reconsider proposed rules that would expand the requirements for posting nutritional labels on prepared food items at stores.

Tags: plan menu labels costly

 

FDA Seeking New Industry User Fees

2013-06-05 09:00:59| Food Processing

Food manufacturers disagree with the FDA's suggestion to add a food processing facility registration fee.

Tags: user industry fees seeking

 

Flamel Technologies Announces FDA Approval Of Bloxiverz

2013-06-05 07:22:35| drugdiscoveryonline News Articles

Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Bloxiverz™ (neostigmine methylsulfate), a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery

Tags: technologies approval announces fda

 

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