The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...
Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, ...
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FDA Expands Label of AZN's Enhertu for New Breast Cancer IndicationAstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...
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