« FDA Requires New Safety Measures for Oral Sodium Phosphate Products | Main | FDA Approvals - Les Weisbrod: Big Pharma Won't Police Itself (HuffingtonPost) "FDA Criticized »

FDA Approvals - OPKO Receives FDA 510(k) Clearance For Spectral OCT SLO Combination


OPKO Receives FDA 510(k) Clearance For Spectral OCT SLO Combination Imaging System (Medical News Today)
OPKO Health, Inc. (NYSE Alternext US:OPK) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to begin marketing in the United States its Spectral OCT SLO Combination Imaging System.

Sirion Therapeutics New Drug Application For Ganciclovir Is Accepted For Review By The FDA For The Treatment Of Ocular ... (Medical News Today)
Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. Food and Drug Administration (FDA). Sirion Therapeutics is seeking approval for ganciclovir as a treatment for herpetic keratitis, an ocular disease caused by the herpes simplex virus.

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.
 

©2006 FDA-News.com. All rights reserved.