Novo Nordisk says its investigational anti-inflammatory drug ziltivekimab failed to reduce the risk of major adverse cardiovascular events in a late-stage study of patients with cardiovascular disease, chronic kidney disease and inflammation.
A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used with biosimilar and interchangeable biosimilar products.
Novo Nordisk says its investigational anti-inflammatory drug ziltivekimab failed to reduce the risk of major adverse cardiovascular events in a late-stage study of patients with cardiovascular disease, chronic kidney disease and inflammation.
A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used with biosimilar and interchangeable biosimilar products.
A new Harvard Law School legal commentary argues that decades of policies designed to accelerate pharmaceutical innovation may have instead encouraged investment in drugs that offer limited clinical benefit while leaving important public health needs underserved.
FDA finalizes a guidance outlining how generic drug developers should evaluate the adhesion performance of transdermal and topical delivery systems.
