news report
FDA Approves First Oral PCSK9 Drug After 56%–59% LDL Cuts vs. Placebo
Lipfendra adds a once-daily tablet to a cholesterol-lowering drug class previously available only by injection; the pivotal endpoint was LDL change at 24 weeks.
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FDA
news report
FDA Revokes Orange B Rule, Proposes Ending Citrus Red No. 2
Orange B’s revocation is final, while the Citrus Red No. 2 action remains a proposal open for comment through August 24.
news report
FDA Approves First Orexin-Targeting Drug for Narcolepsy Type 1
Orzeyful, or oveporexton, is the first approved medicine designed to restore the missing wakefulness signal behind the disorder’s full symptom pattern.