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FDA Approvals - Geron Receives FDA Clearance To Begin World's First Human Clinical


Geron Receives FDA Clearance To Begin World's First Human Clinical Trial Of Embryonic Stem Cell-Based Therapy (Medical News Today)
Geron Corporation (Nasdaq:GERN) announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell (hESC)-based therapy in man.

Abbott Receives FDA CLIA Waiver For Use Of Five Additional Cartridges On The I-STAT Handheld Blood Analyzer (Medical News Today)
Abbott (NYSE: ABT) announced that the U.S. Food and Drug Administration (FDA) has granted waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for five additional test cartridges used by its i-STAT handheld blood analyzer. Cartridges for E3+, EC4+ and 6+ aid the clinician in assessing a patient's metabolic state within a few minutes.

IMPAX Receives Final FDA Approval for Omeprazole 40 mg Capsules (Business Wire via Yahoo! Finance)
HAYWARD, Calif.----IMPAX Laboratories, Inc. , through its generic drug division Global Pharmaceuticals, announced that yesterday the U.S. Food and Drug Administration granted final approval of the Company's Abbreviated New Drug Application for a generic version of Prilosec 40 mg Delayed-release Capsules.
 

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