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The Food and Drug Administration expanded the approval of Kisqali, a drug for metastatic breast cancer, to also treat patients with earlier stages of the disease, drugmaker Novartis said Tuesday. The approval means that tens of thousands of women diagnosed with early-stage breast cancer will have access to a medication that can help prevent their cancer from coming back. The expanded approval is for patients with HR-positive, HER2-negative breast cancer, the most common form of the disease. It comes as rates of breast cancer are increasing in younger women: From 2000 to 2019, rates of breast cancer in women ages 20 to 49 increased by 15.6% according to a study published earlier this year in JAMA Network Open. “You’re always going to be faced with the fact every single day that you have had breast cancer,” she said.

Persons: ”, Eleonora Teplinsky, it’s, Kisqali, Vandana Abramson, Teplinksy, Nikki Odum, ‘ I’m, ’ ”, Odum, Justin, Denise Yardley, ” Odum, Yardley, Sarah Cannon, Komal, Abramson, ” Teplinsky, that’s, “ You’re, “ Organizations: Drug Administration, Novartis, Health, European Society for Medical Oncology, Breast Cancer Research, Vanderbilt, Ingram Cancer Center, Kisqali, Sarah, Sarah Cannon Research Institute, Memorial Sloan Kettering Cancer Center Locations: New Jersey, Barcelona, “, Nashville , Tennessee, ”, Smyrna , Tennessee, Nashville, New York

The Food and Drug Administration’s “hands-off approach” to food additives, including those found in ultraprocessed foods and energy drinks, may allow unsafe ingredients to enter the nation’s food supply, according to the authors of an editorial published Thursday. While food manufacturers can request an FDA review of new ingredients before they are added to products — and they sometimes do — they are not required to do so. From 1990 to 2010, an estimated 1,000 substances were labeled GRAS by manufacturers and were used without notifying the agency, Pomeranz said, citing earlier research. Since then, she added, there have likely been many more ingredients added to the nation’s food supply without the FDA’s oversight. “We have no idea how many substances are in the food supply based on this self-GRAS mechanism,” Pomeranz said.

Persons: ”, Jennifer Pomeranz, “, Pomeranz, ” Pomeranz, Xaq, ” Frohlich, Richard Mattes, ” Mattes, “ It’s Organizations: American, of Public Health, FDA, European Union, NYU School of Global Public Health, Auburn University, Purdue University Locations: India, Japan, GRAS, Alabama, Indiana

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