Results for fda: 318
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UPDATE 2-U.S. FDA warns J&J unit over study of new drug
18 Aug 2009 20:39:13 PST* FDA: unit did not properly monitor records, researchers * Agency withholds name of experimental drug * Shares of J&J barely lower in late morning trade (Adds details from letter, updates share price) WASHINGTON, Aug...
Tag: chemical , pharmaceuticals , FDA , U.S. , Johnson & Johnson , chemicals-data , market data , analysis , industry news -
Antidepressant suicide risk varies by age -US FDA
11 Aug 2009 17:28:51 PST* Antidepressants raise suicide risks in young adults * Older adults not affected, US FDA regulators find CHICAGO, Aug 11 - People under age 25 who take antidepressants have a higher risk of suicide, but...
Tag: chemical , antidepressant , pharmaceuticals , risk , suicide , FDA , chemicals-policy , analysis , industry news -
Wyeth says FDA extends Prevnar 13 review by 3 mos
11 Aug 2009 17:24:01 PST* Says delay needed for FDA to review requested info * Says FDA studying data on vaccine's physical properties NEW YORK, Aug 11 - Wyeth <WYE.N> said on Tuesday that U.S. regulators will take three...
Tag: chemical , Prevnar 13 , pharmaceuticals , vaccine , Wyeth , FDA , chemicals-producer , analysis , industry news -
UPDATE 2-Arthritis drugs raise cancer risk in kids-US FDA
04 Aug 2009 17:01:25 PST* TNF blocker drugs to carry stronger warnings * Cancer risk occurs about 30 months after treatment-FDA (Adds FDA and company comments, background) WASHINGTON, Aug 4 - Blockbuster prescription drugs used to treat rheumatoid arthritis...
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UPDATE 1-US FDA nominee says critical to boost confidence
07 May 2009 17:40:48 PST* FDA nominee to focus on food, drug safety - testimony * Hamburg to testify at Senate hearing Thursday afternoon WASHINGTON, May 7 - President Obama's nominee to run the Food and Drug Administration will...
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UPDATE 2-Obama picks FDA chief, starts new food safety panel
27 Apr 2009 20:24:02 PST*Dr. Margaret Hamburg to head FDA *Dr. Joshua Sharfstein is deputy *HHS and USDA to work out new food safety structure WASHINGTON, March 14 - President Barack Obama chose public health and biological threat expert...
Tag: food , food safety , Barack Obama , people , policy , government , FDA , Americas , U.S. , industry news -
UPDATE 2-US FDA staff cites issues with Atritech device data
21 Apr 2009 11:14:26 PST* Atritech seeks FDA approval, says device is effective * FDA staff points to 13 potential concerns with data * FDA advisory panel meets on Thursday (Adds company comment, details from documents, byline) WASHINGTON, April...
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UPDATE 1-US FDA staff cites issues with Atritech device data
21 Apr 2009 06:15:44 PST* FDA staff points to 13 potential concerns with data * Atritech seeking FDA approval for device * FDA advisory panel to meet April 23 WASHINGTON, April 21 - U.S. health regulatory staff in documents...
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UPDATE 3-US FDA staff says Avastin brain cancer data unclear
29 Mar 2009 17:28:19 PST* FDA staff cites issues with Genentech's Avastin data * Genentech says data support use of drug for brain cancer * FDA advisory panel to review possible new use Tuesday * Company expects FDA final...
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UPDATE 2-U.S. FDA memo backs Sanofi heart drug Multaq
16 Mar 2009 18:07:17 PST* Sanofi heart drug should win US approval, reviewer says * Multaq should have limited claims - FDA reviewer memo * FDA panel to consider drug on Wednesday * Sanofi shares up 3 percent in...
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