Category Medical Devices

Vertex Announces European Medicines Agency Validation for Marketing Authorization Application Extension for KAFTRIO® in Combination With Ivacaftor to Include People With Cystic Fibrosis and Responsive Rare Mutations

Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European Medicines Agency (EMA) has validated a Type II variation application to the Marketing Authorization for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor. The application…

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BIOVECTRA Launches Specialized Capabilities in mRNA Drug Product Development and Biomanufacturing

BIOVECTRA Launches Specialized Capabilities in mRNA Drug Product Development and Biomanufacturing Today BIOVECTRA celebrates the completion of its $90 million plus biologics expansion at the company’s new state-of-the-art Biomanufacturing Centre…

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Phase Genomics Advances Breakthrough Cytogenomics with the Element AVITI System for Acute Myeloid Leukemia

Phase Genomics, Inc., a global innovator for industry-leading genomic solutions, today announced the presentation of new data from the proximity ligation sequencing-based OncoTerra cytogenomics platform on the leading-edge AVITI next-generation…

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Recor Medical Announces U.S. Launch and First Commercial Cases of Paradise Ultrasound Renal Denervation Therapy

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced the first commercial uses of Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system for…

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Castle Announces Early Exploratory Study Data for Potential Development of a Complementary Test to Accompany DecisionDx®-UM That Could Aid in the Early Detection of Uveal Melanomas

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new discovery data from an ongoing study exploring the potential for developing…

Read MoreCastle Announces Early Exploratory Study Data for Potential Development of a Complementary Test to Accompany DecisionDx®-UM That Could Aid in the Early Detection of Uveal Melanomas