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Serious Reaction to Some Anti-Seizure Meds: FDA

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FDA warns of a rare but serious risk of Drug Reaction with Eosinophilia and Systemic Symptoms associated with two anti-seizure dru...

Acelyrin Auditing Izokibep Trial Issues

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Acelyrin says it will have an independent auditor evaluate contractor research organization issues in trials for its izokibep.

Dr. Bernes Selling Unapproved, Adulterated Eye Drops

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FDA warns Tesuque, NM-based Dr. Bernes Whole Health Products that it is marketing adulterated unapproved eye drops.

Malignancy Events with CAR T-Cell Therapies: FDA

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FDA opens an investigation into an identified risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimer...

FDA Warns on Overheating Philips CPAP Devices

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FDA issues a warning on Philips DreamStation 2 continuous positive airway pressure (CPAP) machines and their potential to overheat...

Biden to use Defense Production Act on Shortages

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President Biden says his administration will invoke the Defense Production Act to manufacture essential medicines in the U.S. to m...

Public Meeting on Clinical Study Quality

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FDA and the Duke-Margolis Center for Health Policy announce a hybrid (online/in-person) public meeting 1/31 on Building Quality in...

Mixed Reality Device CGMP Inspection Success

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Researchers say a hybrid pilot mock drug GMP inspection found that on-site investigators were able to interact with remote partici...

Aldeyra Complete Response on Dry Eye NDA

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FDA sends Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treatin...

Novartis Recalls 2 Sandimmune Lots

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Novartis recalls two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottl...