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Medline Convenience Kit Recall is Class 1

[ Price : $8.95]

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 ...

Put Restrictions on Leqvio ANDA or NDA: Petition

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Novartis asks FDA to restrict ANDAs or 505(b)(2) NDAs citing the companys Leqvio as the reference-listed drug.

TX Wins $41.5 Million in Adulterated Drug Settlement

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Texas attorney general Ken Paxton reaches a $41.5 million settlement with Pfizer and Tris Pharma after accusing the companies of p...

Ocuvex Resubmits NDA for Glaucoma Drug

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Sun Pharma Advanced Research Company says that Ocuvex Therapeutics has resubmitted an NDA for PDP-716, more than two years after t...

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...

FDA Warns Indian API Maker Over Quality Lapses

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FDA issues a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered CGMP violations at the companys acti...