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Establishing operational limits is a key issue to consider. These are the limits that are obtained during the operational qualification (OQ) testing over the expected operating range. Read More
Massachusetts-based Azenta is expanding its cold-chain sample management capabilities with the purchase of Luxembourg’s B Medical Systems, a leading cold-chain services provider. Read More
The initial response to the FDA’s trial opening of its Customer Collaboration Portal to premarket device submissions has been encouraging, the agency says. Read More
Karuna Therapeutics’ investigational schizophrenia drug KarXT (xanomeline-trospium) reduced symptoms of the disorder in a late-stage study, with clinically meaningful changes seen within two weeks of beginning treatment. Read More
Regeneron Pharmaceuticals has sued Viatris over the company’s proposed biosimilar of Regeneron’s blockbuster vision loss drug, saying it violates multiple patents. Read More
Data from an ongoing phase 3 study show the investigational PD-L1 antibody sugemalimab buys an extra four months of progression-free time for patients with unresectable stage III non-small cell lung cancer (NSCLC). Read More