* 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...
* 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...
* 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...
* 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...
* 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...
*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...
* 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...
* 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...
* 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...
* 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...