The American journal of medicine
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In 2022, the US Food and Drug Administration (FDA) approved 37 novel drugs. Twenty-four of the 37 (65%) novel drug approvals were reviewed and approved through an expedited review pathway and 20 of the 37 (54%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2022.
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The aim of this study was to determine the impact of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor use on incident sepsis and other severe infections. ⋯ There was neither a beneficial nor a harmful association between PCSK9 inhibitors and risk of sepsis or severe infections. These findings provide reassurance regarding the safety of PCSK9 inhibitors in patients who are concerned about potential drug side effects related to infections.