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FDA Approvals - Cardium's Generx Advances To Phase 3 Following Meeting With FDA


Cardium's Generx Advances To Phase 3 Following Meeting With FDA (Medical News Today)
Cardium Therapeutics, Inc (OTC Bulletin Board: CDTP) announced that Generx(TM) (alferminogene tadenovec) is to be advanced to a Phase 3 clinical trial in women as a potential treatment for myocardial ischemia (insufficient blood flow within the heart muscle), following an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). [click link for full article]

FDA May Urge Stricter Stent Testing by J&J, Rivals (Update4) (Bloomberg.com)
Dec. 6 (Bloomberg) -- U.S. regulators may recommend stricter testing standards for cardiac stents to ensure the devices are safer than those now available, according to a person familiar with new guidelines being developed by the Food and Drug Administration.
 

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