Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Idorsia Pharmaceuticals Quviviq (daridorexant h...
FDA issues two briefing documents to facilitate discussion by the Oncology Drugs Advisory Committee of the risk/benefit assessment of using immune che...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Ojjaara (momelotinib).
Two stakeholders say it is important that FDA state that principles in a question-and-answer guidance on pre-approval manufacturing changes to biosimi...
The U.S. House of Representatives passes the Give Kids a Chance Act (HR 3433) that is intended to address childhood cancer and rare diseases.
FDA releases the form FDA-483 issued following a 2023 inspection at an Eisai drug manufacturing facility in Gifu, Japan.
FDA accepts for review an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) foam 0.3% for treating adults and adolescents ages 12 and ...
FDA releases the form FDA-483 with five observations from a 2023 inspection at the Hugel drug substance and product manufacturing facility in the Repu...
