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Economic Times
19-05-2025
- Business
- Economic Times
Sun Pharma shares in focus after USFDA nod for next-gen skin disorder device
Shares of Sun Pharmaceutical Industries are set to be in focus on Monday after the company announced that it had received approval from the U.S Food and Drug Administration (USFDA) for its next-generation BLU-U Blue Light Photodynamic Therapy (PDT) device, developed for the treatment of actinic keratosis—a precancerous skin condition. ADVERTISEMENT In a stock exchange filing on Friday, Sun Pharma said the USFDA had approved its upgraded PDT system under the agency's Real-Time Review Program. The device treats actinic keratoses, or AKs, in combination with LEVULAN® KERASTICK®—a liquid containing aminolevulinic acid that is used to target minimally to moderately thick lesions on the face, scalp, and upper extremities. According to the U.S. National Center for Biotechnology Information (NCBI), actinic keratosis is often associated with chronic sun exposure, (and) individuals with actinic keratosis may present with irregular, red, scaly papules or plaques on sun-exposed regions of the body. The condition can progress to skin cancer if left untreated. Sun Pharma's upgraded BLU-U device replaces the older fluorescent-tube-based model with modern LED technology, making it 'more compact and easier to use,' the company said.'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, chief executive officer at Sun Pharma (North America).'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,' Gandhi added. ADVERTISEMENT The company's stock has gained 13% over the past year and 2% in the past three months, though it declined 0.6% over the last week. On the technical front, Sun Pharma shares are currently trading below six of their eight key simple moving averages, including the 10-day, 20-day, 30-day, 100-day, 150-day, and 200-day SMAs. The 14-day Relative Strength Index (RSI) stands at 47.7, suggesting a neutral trend. ADVERTISEMENT Also read | Nifty likely to advance towards 25,200-25,800: Analysts (Disclaimer: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of the Economic Times) (You can now subscribe to our ETMarkets WhatsApp channel)
Time of India
19-05-2025
- Business
- Time of India
Sun Pharma shares in focus after USFDA nod for next-gen skin disorder device
Live Events (You can now subscribe to our (You can now subscribe to our ETMarkets WhatsApp channel Shares of Sun Pharmaceutical Industries are set to be in focus on Monday after the company announced that it had received approval from the U.S Food and Drug Administration (USFDA) for its next-generation BLU-U Blue Light Photodynamic Therapy (PDT) device, developed for the treatment of actinic keratosis—a precancerous skin a stock exchange filing on Friday, Sun Pharma said the USFDA had approved its upgraded PDT system under the agency's Real-Time Review Program. The device treats actinic keratoses, or AKs, in combination with LEVULAN® KERASTICK®—a liquid containing aminolevulinic acid that is used to target minimally to moderately thick lesions on the face, scalp, and upper to the U.S. National Center for Biotechnology Information (NCBI), actinic keratosis is often associated with chronic sun exposure, (and) individuals with actinic keratosis may present with irregular, red, scaly papules or plaques on sun-exposed regions of the body. The condition can progress to skin cancer if left Pharma's upgraded BLU-U device replaces the older fluorescent-tube-based model with modern LED technology, making it 'more compact and easier to use,' the company said.'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, chief executive officer at Sun Pharma (North America).'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,' Gandhi company's stock has gained 13% over the past year and 2% in the past three months, though it declined 0.6% over the last the technical front, Sun Pharma shares are currently trading below six of their eight key simple moving averages, including the 10-day, 20-day, 30-day, 100-day, 150-day, and 200-day SMAs. The 14-day Relative Strength Index (RSI) stands at 47.7, suggesting a neutral trend.: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of the Economic Times)
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Business Standard
16-05-2025
- Health
- Business Standard
Sun Pharma gets USFDA approval for new device to treat skin disease
Pharma major Sun Pharmaceutical Industries on Friday said it has received approval from the US Food and Drug Administration (USFDA) for a new medical device that treats a skin disease called actinic keratoses. According to the official website of US National Center for Biotechnology Information (NCBI), the disease is 'often associated with chronic sun exposure, (and) individuals with actinic keratosis may present with irregular, red, scaly papules or plaques on sun-exposed regions of the body". It also states that it is important to treat the disease in its early stages as delay in the treatment can lead to skin cancer. The new device from Sun Pharma treats the disease in combination with LEVULAN® KERASTICK®, a liquid that contains a substance called aminolevulinic acid and is designed for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities. The approved device is an upgraded system of BLU-U Blue Light Photodynamic Therapy (PDT) and uses LED technology for treatment whereas the older version used fluorescent tubes to produce blue light. Sun Pharma said that the approval of the device was granted under the USFDA's Real-Time Review Program, reflecting the robustness of the submission and Sun Pharma's continued collaboration with the agency. The company added that the new device is more compact and easier to use than its predecessor. '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, chief executive offier at Sun Pharma (North America). '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,' Gandhi added.
Yahoo
16-05-2025
- Business
- Yahoo
Sun Pharma Announces FDA Approval of Next Generation BLU-U® Blue Light Photodynamic Therapy Illuminator for Actinic Keratosis
The BLU-U Model 4170E offers a compact, easy-to-use option with the same BLU-U safety and efficacy healthcare professionals have trusted for years. MUMBAI, India, PRINCETON, N.J. and BILLERICA, Mass., May 16, 2025 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and/or associates referred as "Sun Pharma") today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval application (PMA) approval of the next generation of BLU-U® Blue Light Photodynamic Therapy (PDT) Illuminator which features light emitting diode light (LED) panels as a replacement for the previous model's fluorescent tubes. The new model (LED BLU-U) in combination with LEVULAN® KERASTICK® (aminolevulinic acid HCl) Topical Solution, 20%, is indicated for the treatment of minimally to moderately thick actinic keratoses (AK) of the face, scalp, or upper extremities. The new LED BLU-U is approved for the same indications as the previous model but takes up less space in a dermatologist's office, and has a more flexible five-panel shape, improved LED arrangement, lighter weight, and other updated functions that may increase patient comfort and ease of use. "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." The approval of LED BLU-U was granted under FDA's Real-Time Review Program, reflecting the robustness of the submission and Sun Pharma's continued collaboration with the Agency. The LED BLU-U will be available for delivery in the near future. For details regarding availability, ordering, or implementation, please direct inquiries to your Sun Pharma Specialty Dermatology representative. For more information, healthcare professionals are encouraged to visit About Actinic Keratosis (AK)AK is a chronic condition that can lead to skin cancer. AKs are rough, dry, and scaly patches on the skin resulting from extended sun exposure. These spots can vary in size from a tiny pinhead to a quarter and are commonly found on sun-exposed areas such as the face, scalp, arms and hands. About LEVULAN KERASTICK + BLU-ULEVULAN KERASTICK + BLU-U blue light is the only FDA-approved photodynamic therapy (PDT) that effectively targets and clears actinic keratosis (AK) on the face, scalp, arms and hands. LEVULAN KERASTICK (a topical 20% ALA [aminolevulinic acid] solution) + BLU-U blue light photodynamic therapy (PDT) has earned the trust of dermatologists for more than 20 years, offering a proven safe and effective treatment that can eliminate actinic keratoses (AKs) in one or two in-office visits. About Sun Pharmaceutical Industries Limited. (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Sun Pharma Investors: Dr. Abhishek Sharma Tel + 91 22 4324 4324, Ext 2929 Tel Direct + 91 22 43242929 Mobile + 91 98196 86016 E-mail Media: Gaurav Chugh Tel +91 22 4324 4324, Ext 5373 Tel Direct +91 22 4324 5373 Mobile +91 98104 71414 E-mail Media Contact (USA): James FreemanHead of CommunicationsSun Pharmaceutical Industries, Inc. (978) 808-6956 View original content to download multimedia: SOURCE Sun Pharma
