FDA grants Eli Lilly a breakthrough therapy designation for olomorasib as a monotherapy for treating adult patients with advanced pancreatic cancer.
Sandoz reaches agreements totaling about $479 million to resolve most of its remaining exposure in long-running U.S. litigation alleging anticompetiti...
FDA regulatory experts support the agency's new "Operation Trialblazer" initiative as an important step toward accelerating drug development but cauti...
FDA cites Australian manufacturer Veganic SKN Limited for multiple current good manufacturing practice deficiencies following a 7/2025 inspection of i...
A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used with biosimilar and in...
A new Harvard Law School legal commentary argues that decades of policies designed to accelerate pharmaceutical innovation may have instead encouraged...
FDA finalizes a guidance outlining how generic drug developers should evaluate the adhesion performance of transdermal and topical delivery systems.
Novo Nordisk says its investigational anti-inflammatory drug ziltivekimab failed to reduce the risk of major adverse cardiovascular events in a late-s...
