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You are here: Industry Insights > Breakthrough Designation

News List

SpeeDx receives FDA breakthrough designation for ResistancePlus®GC biospectrumasia
June 18, 2019
New diagnostic test enables antibiotic resistance testing and stewardship in gonorrhea treatment
La Jolla Pharma Gets Breakthrough Designation for Malaria Treatment contractpharma
April 26, 2019
La Jolla Pharmaceutical Company was granted Breakthrough Therapy designation by the FDA for the New Investigational Drug Product, LJPC-0118, for the treatment of severe malaria.
FDA grants Breakthrough Designation to Paige.AI biospectrumasia
March 12, 2019
The FDA’s Breakthrough Device designation is granted for technologies that have the potential to provide for more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases