FDA Raises Manufacturing Concerns, Delays Unicycive's Kidney Disease Drug Approval - Unicycive Therapeutics (NASDAQ:UNCY)

FDA issues complete response letter for Unicycive's kidney drug

Unicycive drops 25% following Complete Response Letter

FDA Raises Manufacturing Concerns, Delays Unicycive's Kidney Disease Drug Approval - Unicycive Therapeutics (NASDAQ:UNCY)

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on Monday for Unicycive Therapeutics, Inc.’s (NASDAQ:UNCY) New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Hyperphosphatemia is a condition characterized by elevated phosphate levels in the blood, most commonly resulting from impaired kidney function, and can lead to comp…

FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

The letter cited deficiencies previously identified at a third-party manufacturing vendor unrelated to oxylanthanum carbonate (OLC).

Stryker in Portage Receives FDA Clearance for Incompass Total Ankle System - DBusiness Magazine

Stryker’s Incompass Total Ankle System integrates the technologies of the Inbone and Infinity systems into a single, comprehensive solution. // Photo courtesy of Stryker Stryker, the medical technologies provider in Portage (near Kalamazoo), has received U.S. Food and Drug Administration 510(k) clearance for the Incompass Total Ankle System, an implant intended for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degen…

Release - Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis - Channelchek

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