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doi: 10.3389/fendo.2025.1734431 Received 28 October 2025 Revised 26 November 2025 Accepted 02 December 2025 Published 17 December 2025 Volume 16 - 2025 Edited by Sandhya Srikant Visweswariah, Indian Institute of Science (IISc), India Reviewed by Gargi Meur, National Institute of Nutrition (ICMR), India Nikhil R

FDA identified particular concern for proposed injectable exposure because no clinical immunogenicity or aggregation studies were available

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