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A Louisiana federal judge managing the tide of lawsuits against the blood thinner Xarelto (rivaroxaban) ordered them to be prepared for trial in individual federal courts nationwide, with selection and discovery to take place in two waves of 600 cases each. Read More
The biggest challenge for the FDA’s 10-year-old Sentinel program for post-market safety monitoring of medical products is having to deal with a wide range of partners and data sources, according to CDER Deputy Director Robert Ball. Read More
Switching from a reference medicine to a biosimilar does not affect patient safety, according to a data review by a research team that looked at 90 studies involving 14,225 subjects for signs of increased immunogenicity associated with switching. Read More
The European Medicines Agency released a draft revised guideline for safety and efficacy follow-up of advanced therapy medicinal products, including gene therapies, cell therapies and tissue engineering. Read More
Taking some opioid painkillers increases the risk of deadly infections, according to an analysis of data from TennCare, Tennessee’s state Medicaid program. Read More
The biggest challenge for the FDA’s 10-year-old Sentinel program for post-market safety monitoring of medical products is having to deal with a wide range of partners and data sources, according to CDER Deputy Director Robert Ball. Read More