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The FDA is investigating reports that the osteoporosis medicine Prolia (denosumab) may cause dangerously low calcium levels in the blood of patients with advanced kidney disease, particularly those on dialysis. Read More
Planning for a drug or device recall, training for it and executing it with a heaping helping of humility are the key steps to managing a recall without sinking your business, according to Matt Walker, director of business development for the risk management company Sedgwick. Read More
The first-line oral diabetes drug metformin has been linked to 40 percent higher risk of birth defects in the offspring of men who took it during the three months before conception. Read More
The EMA previously recommended adding transverse myelitis to the list of possible side effects linked with Johnson & Johnson’s COVID-19 vaccine. Read More