US Food and Drug Administration (FDA)

EMA finds no link between GLP-1 receptor agonists and suicidal thoughts

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has confirmed that no update to product information is warranted.…

FDA ‘evaluating regulatory action’ over link between GLP-1 receptor agonists and suicidal thoughts

The US Food and Drug Administration said it had received reports of suicidal ideation in patients taking GLP-1 receptor agonists through its adverse events reporting system.…

Colchicine for cardiovascular disease: is UK clinical practice missing out?

A deep dive into whether colchicine, an ancient treatment for inflammation, has a future in cardiovascular disease therapy in the UK.…

Why we need to talk about sex and clinical trials

The under-representation of women in clinical trials is slowly being addressed, but we cannot move towards truly personalised healthcare unless we have an equal balance of the sexes in all new medicine trials.…

FDA approves omega-3 fatty acid to reduce cardiovascular risk

The US Food and Drug Administration has approved the omega-3 fatty acid icosapent ethyl as an adjunctive therapy to reduce the risk of cardiovascular events in adults with elevated triglyceride levels.…

Half of all safety warnings issued to drug manufacturers in India and China

The majority of warnings from European and US drug regulators are to drug manufacturing sites in India and China, raising concerns about the fragility of the global supply chain.…

FDA approves new generic valsartan to address shortages

The US Food and Drug Administration has approved a new generic valsartan to help relieve recent shortages of the medicine.…

FDA announces review of opioid approval process

The US Food and Drug Administration has said it will review its approach to approvals of new opioid analgesics in light of the ongoing opioid crisis in the United States.…

FDA approves first new flu drug in nearly 20 years

The first new influenza antiviral for almost two decades has been approved for use in the United States by its drugs safety watchdog.…

FDA launches ‘biggest ever enforcement effort’ against e-cigarette use by young people

The US drug safety watchdog is targeting the sale of e-cigarettes to children, which it says is reaching “epidemic proportions”, in its biggest ever enforcement campaign.…