| |MAY 20259Sun Pharmaceutical Industries Limited reported that the U.S. Food and Drug Administration (FDA) has now approved premarket approval application (PMA) for the new, next generation BLU-U PDT Illuminator equipped with LED panels instead of fluorescent tubes used in the earlier model.LED BLU-U has been approved, with LEVULAN KERASTICK, for handling actinic keratoses on the face, head or arms, depending on how thick they are.The new LED BLU-U can still be used for the same medical conditions as the previous model, but it needs less space in a dermatology practice and is easier to move due to its improved five-panel shape, better LEDs, lighter weight and other recent upgrades."We are pleased to receive the FDA's approval of LED BLU-U and look forward to seeing the positive impact this next generation device will have for those living with actinic keratosis," said Abhay Gandhi, Sun Pharma North America CEO."As a company committed to innovation, we are confident that this new LED BLU-U model will provide improved efficiency and reliability while maintaining the safety and efficacy that healthcare professionals and people with AKs have come to trust from Sun Pharma."Sun Pharma's submission to the Real-Time Review Program was considered strong enough by FDA to approve LED BLU-U.Shipments of the LED BLU-U will be made soon. Please register your request or ask for support, with your Sun Pharma Specialty Dermatology representative. POScientists at the National Institutes of Health (NIH) have found that alterations in the structure and cell composition of breast connective tissue, or stroma, are associated with a heightened risk for aggressive breast cancer in women with benign breast disease. This process, known as stromal disruption, can also forecast worse survival among women who already have invasive breast cancer. The results provide novel opportunities for utilizing stromal disruption as a low-budget biomarker for the detection of high-risk individuals and guiding directed prevention and treatment protocol.Researchers examined 9,220 samples of breast tissue, including healthy tissue, benign breast disease biopsies, and invasive cancer. Machine learning was employed to detect extremely subtle architectural and cellular alterations in stromal tissue undetectable with routine screening.Women having benign breast disease showing extensive stromal disturbance were more likely to develop aggressive breast cancer and had a faster progression than those who had minimal changes--highlighting its potential as an early-warning biomarker.Stromal disruption was more common in those women having already established risk factors such as obesity, younger age at childbirth, multiple births, Black race, and family history of breast cancer, suggesting a shared biological pathway.In invasive breast cancer, particularly estrogen receptor-positive tumors, more disruption was associated with more virulent tumors and worse survival.Most importantly, stromal disruption is cheap to screen for and might be particularly valuable in low-resource environments. Investigators urge additional studies to determine whether anti-inflammatory medication or lifestyle modification may prevent such tissue changes and lower cancer risk in high-risk populations. POSUN PHARMA SECURES FDA NOD FOR NEW SKIN DISEASE DEVICESTROMAL CHANGES MAY SIGNAL RISK OF AGGRESSIVE BREAST CANCER
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