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The EMA’s Committee for Medicinal Products for Human Use is recommending approval for six drugs within the EU and another for export-only from EU countries. Read More
The UK’s National Institute for Health and Care Excellence is recommending reimbursement of Novartis’ drug combination Mekinist and Tafinlar for treating unresectable or metastatic melanoma in patients with BRAF V600 mutations. Read More
Drugmakers are expected to collect individual cases of suspected adverse reactions linked to off-label use but not individual reports when there has been no associated adverse event, the EMA said Friday. Read More
Xellia Pharmaceuticals and the FDA have agreed on a modified consent decree so Xellia can resume manufacturing at the Bedford, Ohio, site it purchased from Ben Venue Laboratories. Read More
The FDA expects drugmakers to have quality agreements with their suppliers, but how those agreements are crafted says a lot about a company’s internal auditing program. Read More
The FDA slammed Denmark’s Novo Nordisk for numerous GMP issues in a 13-item Form 483 for inadequate controls for sterility, environmental monitoring, labeling and written procedures. Read More