The U.S. FDA accepted Telix Pharmaceuticals Ltd.’s new drug application for TLX-007-CDx, a new cold kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer.
Owens & Minor Inc. plans to acquire Rotech Healthcare Holdings Inc. in a $1.36 billion cash transaction expected to close by year end. The deal shows serious commitment to a strategy outlined in December to build out its home health business.
The U.S. FDA literally wasted no time in posting twin warning letters to two companies in China that manufacture syringes that were the subjects of multiple recalls in the U.S.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Camber Spine, Saphetor, Think Surgical, Zimvie.
Paige AI Inc.’s partnership with Microsoft Corp., announced last September, appears to have paid off quickly, with a study published in Nature Medicine demonstrating that their jointly developed image-based artificial intelligence model, Virchow, detects 16 cancer types as well or better than tissue-specific clinical-grade models.
The U.S. FDA cited Criticare Technologies Inc. for significant lapses in the company’s corrective and preventive action procedures, which suggests a need for outside certification of compliance because this problem was also observed in a warning letter from 2017.
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