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White House Sought Resignation of Top Makary Aide

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New reporting finds that the White House recently requested the resignation of a senior aide to FDA commissioner Marty Makary, hig...

Intersurgical Recalls Video Laryngoscope Due to Safety

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Intersurgical recalls (Class 1) its i-View Video Laryngoscope, citing serious safety risks that could potentially lead to severe i...

Voucher Program Looks Like a Make-a-Deal Process: Experts

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Three Harvard medical professors raise concerns over FDAs review voucher program that they say could politicize drug approvals and...

FDA Posts Withdrawal Notice for Intercepts Ocaliva

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FDA posts a Federal Register notice finalizing the withdrawal of Intercept Pharmaceuticals Ocaliva (obeticholic acid) from the U.S...

FDA Issues Safety Notice on Nitric Oxide Delivery System

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FDA issues a correction notice for NOxBOX Ltd.s NOxBOXi Nitric Oxide Delivery System after reports of dosing fluctuations when the...

Keytruda/Padcev Combo OKd for Bladder Cancer

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FDA approves Mercks checkpoint inhibitor Keytruda (pembrolizumab) in combination with Astellas and Pfizers antibody drug conjugate...

FDA Flags SK Life Sciences Xcopri TV Ad as Misleading

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FDA issues an untitled letter to SK Life Science, raising concerns over a direct-to-consumer television advertisement for its seiz...

Makary, RFK, Jr., Feuding Over Vaccines: Politico

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Politico reports that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are feuding over vaccine safety stud...

Medline Convenience Kit Recall is Class 1

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FDA says the Medline 8/22 recall of three models of surgical convenience kits that were not sterilized is Class 1.

FDA OKs Regenerons High-Dose Eylea

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FDA approves Regeneron Pharmaceuticals Eylea HD (aflibercept 8 mg) for treating macular edema following retinal vein occlusion.