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- Merck's Lipfendra pill receives FDA approval as first oral PCSK9 cholesterol treatmentThe U.S. Food and Drug Administration approved Lipfendra, an oral medication from Merck that lowers low density lipoprotein cholesterol. The drug blocks the PCSK9 protein, making it the first pill…
- 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…