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Xeljanz, a Janus Kinase Inhibitor, is FDA-approved for several indications, including for patients with moderate-to-severe active ulcerative colitis. Read More
South Korean devicemaker SD Biosensor (SDB) has inked a $1.53 billion purchase deal with Cincinnati, Ohio-based Meridian Bioscience, gaining an expanded foothold in the U.S. market. Read More
Texas Medical Technology received a Form 483 from the FDA for a variety of lapses observed during a Feb. 16 to March 3 inspection at its Houston facility, ranging from inadequate device records to ineffective medical device reporting (MDR) procedures. Read More
Leading devicemakers have pushed back against the FDA’s proposed annual appraisals of companies that participate in the agency’s Voluntary Improvement Program (VIP). Read More
The FDA’s annual announcement of planned enhancements to its electronic medical device report (eMDR) portal advises devicemakers that use the agency’s Electronic Submissions Gateway (ESG) to update their submission systems accordingly. Read More