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FDA Licenses First U.S. Freeze-Dried Plasma Product
Ezplaz can be stored at room temperature and rapidly reconstituted for adult transfusion when other plasma products are unavailable.
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U.S. Food and Drug Administration
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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 Proposes Mandatory GRAS Notices
The proposal would replace a voluntary notification system for many generally recognized as safe uses; comments are due Dec. 9, and the rule is not yet final.
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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.
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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.
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FDA Picks Dexcom for First TEMPO Digital Health Pilot
The glucose program will generate real-world evidence inside Medicare’s ACCESS model as FDA plans up to about 10 participants in each of four clinical-use areas.
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FDA Approves First Regulatory T-Cell Therapy for Stem-Cell Transplants
Tregzi improved one-year chronic GVHD-free survival to 78% in a randomized trial of 187 adults, compared with 38.4% after a standard transplant.
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The 1.59-Million-Dozen Egg Recall Comes Down to Three Carton Codes
Roughly 19.1 million eggs are covered, but brand alone does not identify them. The plant code, Julian date and sell-by window must line up.