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A federal judge dismissed more than 40 states’ claims against the parent company that manufactures Suboxone in a suit accusing it of suppressing generics. Read More
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The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1.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