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Posted On: 05/11/2017 8:34:58 AM
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SYN-004 (Ribaxamase) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Prevention of Clostridium difficile Infection
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May 11, 2017
-- FDA Action Marks First Breakthrough Therapy Designation for Clinical Program Designed to Prevent Primary Clostridium difficile Infection --
-- Type-B Meeting Anticipated to Discuss Potential for Expedited Drug Development Strategy --
ROCKVILLE, Md., May 11, 2017 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for SYN-004 (ribaxamase) for the prevention of Clostridium difficile infection. SYN-004 (ribaxamase) is the Company's first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by certain intravenous (IV) beta-lactam antibiotics.
http://ir.syntheticbiologics.com/press-releas...gh-therapy
See ya shorty!
Download as PDF
May 11, 2017
-- FDA Action Marks First Breakthrough Therapy Designation for Clinical Program Designed to Prevent Primary Clostridium difficile Infection --
-- Type-B Meeting Anticipated to Discuss Potential for Expedited Drug Development Strategy --
ROCKVILLE, Md., May 11, 2017 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for SYN-004 (ribaxamase) for the prevention of Clostridium difficile infection. SYN-004 (ribaxamase) is the Company's first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by certain intravenous (IV) beta-lactam antibiotics.
http://ir.syntheticbiologics.com/press-releas...gh-therapy
See ya shorty!
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