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News 2026-09-10 05:45 UTC

Ascelia Pharma completes FDA Type A meeting on Orviglance NDA

Ascelia Pharma completed a previously scheduled Type A meeting with the FDA on September 9, 2026, regarding the Complete Response Letter (CRL) for the Orviglance New Drug Application (NDA). The meeting was held to discuss the issues raised by the CRL.