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Medical Devices

Intersurgical Recalls Video Laryngoscope Due to Safety

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

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Human Drugs

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

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

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Human Drugs

FDA Posts Withdrawal Notice for Intercepts Ocaliva

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

Medical Devices

FDA Issues Safety Notice on Nitric Oxide Delivery System

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

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Human Drugs

Keytruda/Padcev Combo OKd for Bladder Cancer

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

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Human Drugs

FDA Flags SK Life Sciences Xcopri TV Ad as Misleading

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

Medical Devices

Medline Convenience Kit Recall is Class 1

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

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Human Drugs

FDA OKs Regenerons High-Dose Eylea

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

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Human Drugs

Nuvalent NDA for ROS1 Inhibitor in Lung Cancer

FDA accepts for review a Nuvalent NDA for zidesamtinib, a next-generation ROS1-selective tyrosine kinase inhibitor being developed for certain adults ...

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Human Drugs

Guidance Answers More Expanded Access Questions

Two Arnall Golden Gregory attorneys outline highlights in a new FDA question-and-answer guidance on expanded access and suggest ways for industry to u...