Ascelia Pharma has announced that the FDA has accepted to review the company's New Drug Application (NDA) for Orviglance. The FDA has set a PDUFA date of July 3, 2026. The product has orphan drug status and is based on nine clinical studies including the Phase III SPARKLE study that showed statistically significant results. The global market potential is estimated at USD 800 million.
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Published November 17, 2025
Ascelia Pharma receives FDA acceptance for Orviglance application
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News Desk [email protected]
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