FDA Approves TAS-102 for Treating Adults With Gastric/GEJ Cancer
February 25th 2019The drug is indicated for those patients who were previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
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Detection of Impurity Prompts Company to Recall 1 Lot of Combination Tablets
February 23rd 2019Macleods Pharmaceuticals Limited has voluntarily recalled 1 lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level, due to the detection of trace amounts of an unexpected impurity found in the product that is above the acceptable daily intake levels released by the FDA.
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Hepatitis C Antivirals Reduce All-Cause Mortality, Liver Cancer
February 21st 2019Longitudinal study of direct-acting antivirals for hepatitis C virus infection finds that treatment provides clinical benefit beyond virologic response, reducing risk for both all-cause mortality and for liver cancer.
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FDA Grants Breakthrough Therapy Designation for Primary Biliary Cholangitis Therapy
February 20th 2019Seladelpar would be indicated for patients with primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) who have an inadequate response to UDCA or as a monotherapy in adults unable to tolerate UDCA.
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