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As expected, Pfizer will pay $784.6 million to settle Justice Department allegations that a subsidiary deliberately reported inflated prices to Medicaid for two drugs. Read More
The FDA has extended the PDUFA date of Dynavax’s investigational hepatitis B vaccine Heplisav-B by three months to review new data in the company’s resubmitted BLA. Read More
A complete response letter to Otsuka Pharmaceutical from the FDA shot down the company’s application for a drug/device combination product, saying the agency needs more data. Read More
Actavis Laboratories was hit with a two-observation Form 483 after the FDA unearthed potential issues with product storage and recordkeeping. Read More