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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...

Woodcock Urges Stronger FDA Role in Updating Generic Labels

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Former FDA principal deputy commissioner Janet Woodcock and policy experts from Duke University call on the agency to adopt new to...

FDA Probes Death Associated With Takedas Adzynma

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FDA investigates the death of a pediatric patient with congenital thrombotic thrombocytopenic purpura who developed neutralizing a...

Sterility Failures Flagged at Indian Injectable Drug Maker

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FDA investigators cite Immacule Lifesciences Private Limited, a sterile drug contract manufacturer in Himachal Pradesh, India, for...

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...