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The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury.
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FDA Approves New Treatment for Congenital Adrenal Hyperplasia
FDA Approves New Treatment for Congenital Adrenal Hyperplasia
http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-congenital-adrenal-hyperplasia
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FDA Roundup: December 13, 2024
FDA Roundup: December 13, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-13-2024
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Buy-herbal.com Issues Voluntary Nationwide Recall of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules Due to Undeclared Furosemide, Dexamethasone and Chlorpheniramine
12th December 2024, Flushing, New York, Buy-herbal.com is voluntarily recalling all lots within expiry of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules to the consumer level. FDA analysis has found these products to contain undeclared Furosemide, Dexamethasone and Chlorpheniramine. Furosemide was fou
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Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication – Serious Liver Injury Being Observed in Patients without Cirrhosis
Based on its review of postmarket clinical trial data, the U.S. Food and Drug Administration (FDA) identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver.
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Early Alert: Infusion Pump Issue from Fresenius Kabi USA
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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FDA Roundup: December 10, 2024
FDA Roundup: December 10, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-10-2024
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FDA Roundup: December 6, 2024
FDA Roundup: December 6, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-6-2024
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Syringe Recall: Cardinal Health Removes Certain Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs due to Incompatibility with Needleless Connectors
Monoject U-100 1 ml Insulin Syringe Luer-Lock with Tip Cap Soft Pack is used for IV insulin. Certain lots are incompatible with needleless connectors.
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FDA Roundup: December 3, 2024
FDA Roundup: December 3, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-3-2024