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FDA Approvals - Spectral Presents Data On The Clinical Utility Of EAA(TM) At


Spectral Presents Data On The Clinical Utility Of EAA(TM) At 13th Annual Critical Care For Endotoxemia Conference In ... (Medical News Today)
Spectral Diagnostics Inc. (TSX:SDI) announced that it presented new findings demonstrating the clinical utility of its EAA(TM) Endotoxin Activity Assay, the only FDA cleared diagnostic for the measurement of endotoxin, at the 13th Annual Critical Care for Endotoxemia congress.

Kensey Nash Announces IDE Submission For Cartilage Repair Device (Medical News Today)
Kensey Nash Corporation (Nasdaq: KNSY) announced that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to study the use of the Company's unique biomaterials technology for treating articular cartilage defects of the knee.

Gilead Receives Response From U.S. FDA On Company's Request For Formal Dispute Resolution For Aztreonam For Inhalation ... (Medical News Today)
Gilead Sciences, Inc. (Nasdaq:GILD) announced that the company has received a response from the U.S. Food and Drug Administration (FDA) to its appeal, submitted under the formal Dispute Resolution process, regarding the Agency's Complete Response Letter for its New Drug Application (NDA) for aztreonam for inhalation solution.
 

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