SQUAWK/NEWS
Account
Theme
Account
Menu
Live News REGULATION FLASH L impact

Unicycive Therapeutics, Inc. (UNCY) Resubmits NDA for Oxylanthanum Carbonate

Unicycive resubmitted its NDA for oxylanthanum carbonate, expecting FDA acceptance within 30 days and a six—month review clock. The resubmission uses a new CMC vendor with an FDA “No Action Indicated” 2024 inspection.Material DetailsContext by AI AnalystThis is a mid-cycle regulatory update after p…

UNCY