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Two drug trade associations support an FDA approach to postapproval manufacturing changes in biosimilar and interchangeable biosim...[ Price : $8.95]
FDA approves AstraZenecas Tagrisso for some non-small cell lung cancers.[ Price : $8.95]
Lilly asks an Indiana federal court to overturn an FDA determination that the companys retatrutide is a drug rather than a biologi...[ Price : $8.95]
FDA warns Wilmington, MA-based Azurity Pharmaceuticals it is manufacturing and marketing unapproved new drugs with CGMP violations...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Idorsia Pharmaceuticals Quv...[ Price : $8.95]
FDA issues two briefing documents to facilitate discussion by the Oncology Drugs Advisory Committee of the risk/benefit assessment...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Ojjaara (m...[ Price : $8.95]
Two stakeholders say it is important that FDA state that principles in a question-and-answer guidance on pre-approval manufacturin...