FDA

FDA Lifts U.S. Clinical Holds on CARsgen® According to Investing.com

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FDA Lifts U.S. Clinical Holds on CARsgen® According to Investing.com

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK) has recently announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical holds on clinical trials of three of its CAR T-cell therapies in the United States. These therapies include zevorcabtagene autoleucel (zevor-cel, CT053), which targets BCMA, satricabtagene autoleucel (satri-cel, CT041), targeting Claudin18.2, and CT071, … Read more

FDA finds quality issues at Novo’s primary Ozempic facility

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FDA finds quality issues at Novo’s primary Ozempic facility

Novo Nordisk A/S was recently found to have quality lapses at a drug production plant in Denmark that manufactures the popular medicines Ozempic and Wegovy. The plant, located in Kalundborg, Denmark, was found to lack information demonstrating that the water used in drug production was adequately controlled for certain microorganisms, as per a report from … Read more