Federal Register notice: FDA, CDC, and NIH announce an 11/25 public workshop entitled Live Biotherapeutic Products to Prevent Necrotizing Enterocoliti...
Two drug trade associations support an FDA approach to postapproval manufacturing changes in biosimilar and interchangeable biosimilar products.
FDA approves AstraZenecas Tagrisso for some non-small cell lung cancers.
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...
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...
