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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
An Illinois judge denied a request from Abbott Laboratories to throw out a suit accusing the drugmaker of failing to properly warn of safety risks associated with its drug Depakote. Read More
The European Medicines Agency added answers to 60 new questions in its list of inquiries from stakeholders regarding the November launch of its new EudraVigilance drug safety reporting program. Read More
More than 6,000 plaintiffs filed similar cases against the company, but the verdict is the second one against AbbVie in a series of “bellwether” trials. Read More
Drug wholesaler Amerisourcebergen agreed in federal court to pay $260 million and plead guilty to violating federal drug law via a criminal scheme to sell cancer drugs illegally repackaged in pre-filled syringes. Read More
The FDA launched a new search dashboard for its adverse event reporting database, promising a more user-friendly method for industry and the general public to access the agency’s safety and surveillance data. Read More
Women should avoid pregnancy for six months after ending treatment with certain anticancer drugs to keep the drugs from harming an embryo or fetus, the FDA recommended in draft guidance. Read More
Manufacturers of short-acting opioids will be required to offer the kind of doctor training in administering the medications that their extended-release counterparts have been directed to provide since 2012, FDA Commissioner Scott Gottlieb said. Read More