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- Merck secures US approval for the first oral PCSK9 cholesterol-lowering pill, edging out AstraZenecaMerck has received the United States regulatory clearance for an oral PCSK9 inhibitor, marking the first time a pill of this class has been approved for cholesterol management. The approval comes…
- CDER plans new guidance on AI, electronic safety report submissions, and moreThe US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…