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The European Medicines Agency’s pharmacovigilance committee recommended additional restrictions on Biogen’s Zinbryta (daclizumab), after reviewing its effects on the liver. Read More
The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay, and how to request reconsiderations of user fee assessments. Read More
An EU regulation meant to boost pediatric drug development has led to more medicines for children since it was adopted, although actual use of new products has not increased at the same pace, a European Commission report said. Read More
FDA Commissioner Scott Gottlieb told lawmakers the agency will work to break the stigma associated with medication-assisted treatments for opioid dependence and addiction. Read More
Medicare administrators could negotiate lower prices with drug companies, potentially saving the federal government billions of dollars a year, under legislation House and Senate Democrats are introducing in Congress. Read More