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New FDA-approved labeling for the antibiotic meropenem adds another pediatric indication to the drug’s portfolio, this time for treating complicated intra-abdominal infections in children younger than three months old. Read More
Six years after promising a web-based alternative to its electronic submissions gateway, the FDA has launched a drug safety reporting portal for companies with a small number of adverse event reports. Read More
The Arkansas attorney general agreed to a $7.75 million settlement with Johnson & Johnson over its marketing of the antipsychotic Risperdal, just over a year after the state’s top court reversed a $1.2 billion verdict. Read More
The European Medicines Agency is taking a hard look at whether patients taking inhaled corticosteroids for chronic obstructive pulmonary disease are at higher risk for pneumonia. Read More
The FDA may be considering new label warnings for type 2 diabetes drugs containing the active ingredients canagliflozin, dapagliflozin and empagliflozin, in the wake of reports linking the drugs to a serious blood condition. Read More