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Omeros Confirms Submission of Response to FDA Regarding the BLA for Narsoplimab in the Treatment of HSCT-TMA

Omeros Corporation confirmed that earlier this month the company submitted to the U.S. Food and Drug Administration (FDA) its response to the Agency’s Complete...

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...
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