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News Archive
Given the rapid spread of COVID-19 and its relatively high mortality, filling the gap for coronavirus-specific drugs is urgent.
The ongoing meningitis outbreak and its impact on patients and their families is a tragedy, and our hearts go out to the patients and their families who have suffered as a result of these events. The FDA's top priority is to fully contain the health risks associated with the outbreak as quickly as possible, and we will continue to work tirelessly to do so.
The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency's public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.
The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a "BRCA" gene mutation.
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