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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Murilo Freitas - 04:00, 9 de October de 2025160
The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

http://www.fda.gov/safety/medical-product-safety-information/fda-approves-labeling-changes-include-boxed-warning-immune-effector-cell-associated-enterocolitis

 
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Trividia Health, Inc. Initiates Voluntary Recall of Limited Number of TRUE METRIX® Blood Glucose Meters

Murilo Freitas - 04:00, 6 de October de 2025128
(FT. LAUDERDALE, FL) –October 7, 2025 – Trividia Health, Inc., announced today that it is initiating a voluntary recall of a limited number of TRUE METRIX® Self-Monitoring Blood glucose meters co-branded under the Good Neighbor Pharmacy® brand and distributed in the United States.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/trividia-health-inc-initiates-voluntary-recall-limited-number-true-metrixr-blood-glucose-meters

 
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