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...
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...
FDA issues a revised draft guidance updating its recommendations for how generic drug developers should evaluate the skin irritation and sensitization...
FDA approves Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adu...
