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Pathogenomix granted FDA Breakthrough Device Designation

Pathogenomix Inc., a Next Generation Sequencing, pathogen diagnostic company, announced that the US Food and Drug Administration (FDA) has granted it a Breakthrough Device...

Nevro Announces FDA Approval for its 10 kHz Spinal Cord Stimulation System

Nevro Corp., a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, announced receipt of FDA approval...

SK Life Science Announces FDA Clearance of IND Application for Its Oncology Candidate.

SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company, announced that the U.S. Food and Drug Administration...

CARsgen Announces CT041 CAR T-cell Product Candidate Granted RMAT Designation by the FDA

CARsgen Therapeutics Holdings Limited , a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced...

Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

The U.S. FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary...
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