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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...

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.

Nuvalent NDA for ROS1 Inhibitor in Lung Cancer

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

Guidance Answers More Expanded Access Questions

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Two Arnall Golden Gregory attorneys outline highlights in a new FDA question-and-answer guidance on expanded access and suggest wa...

Cotton Asks DoJ Probe of Counterfeit Drugs

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Sen. Tom Cotton poses questions for attorney general Pam Bondi about the Justice Departments activities to stop counterfeit drugs ...