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...
FDA clears a B. Braun Medical 510(k) for the Introcan Safety 2 Deep Access IV Catheter.
FDA warns Wilmington, MA-based Azurity Pharmaceuticals it is manufacturing and marketing unapproved new drugs with CGMP violations.
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...
