Vanda Pharmaceuticals criticizes FDA for wrongly claiming that recent staff cuts and a new commissioner causes it to delay a company request for a hea...
Akeso says its ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous non-small cell lung c...
FDA warns ICU Medical that its Minneapolis, MN-based Smiths Medical ASD unit is illegally marketing adulterated and misbranded infusion pumps.
Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second year of its voluntary Quality Management Maturity Pr...
FDA Matters founder Steven Grossman says FDA commissioner Martin Makary and the Trump administration are at a crossroads and need to decide whether th...
The International Council for Harmonization endorses and releases for comment its Q1 guidance on drug product stability testing.
FDA says it has received reports of adverse effects associated with using unapproved compounded topical finasteride products.
FDA Office of Prescription Drug Promotion director Catherine Gray and deputy director Mark Askine resign their posts in the wake of their Office havi...
