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Human Drugs

Serious Reaction to Some Anti-Seizure Meds: FDA

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

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Human Drugs

Acelyrin Auditing Izokibep Trial Issues

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

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Human Drugs

Dr. Bernes Selling Unapproved, Adulterated Eye Drops

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

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Medical Devices

Malignancy Events with CAR T-Cell Therapies: FDA

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

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Medical Devices

FDA Warns on Overheating Philips CPAP Devices

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

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Human Drugs

Biden to use Defense Production Act on Shortages

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

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Human Drugs

Public Meeting on Clinical Study Quality

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

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Human Drugs

Mixed Reality Device CGMP Inspection Success

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

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Human Drugs

Aldeyra Complete Response on Dry Eye NDA

FDA sends Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treating dry eye disease.

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Human Drugs

Novartis Recalls 2 Sandimmune Lots

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