New Drug Application Rejection

Safety Concerns Doom Akebia’s Chronic Kidney Disease Drug

Anemia, Business, Chronic Kidney Disease, Clinical Trials, Complete Response Letter, Drug Safety Concerns, FDA, New Drug Application Rejection, R&D, Stocks

The U.S. FDA rejected Cambridge, Massachusetts-based Akebia Therapeutics’ New Drug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).

March 30, 2022/by BioSpace

Avenue Therapeutics Plunges as FDA Rejects NDA for IV Tramadol

Acute Pain, Business, Clinical Trials, Complete Response Letter, Intravenous Formulation, New Drug Application Rejection, Premarket Trading, R&D, Shares

Shares of Avenue Therapeutics plunged in trading after the company announced the U.S. Food and Drug Administration rejected the New Drug Application for intravenous tramadol over safety concerns.

October 13, 2020/by Andrew Humphreys