Brief: FDA Provides Akebia Therapeutics a Path Forward For Vadadustat

Akebia Therapeutics

30/05/2023 12:49

May 30 (Reuters) - Akebia Therapeutics Inc  AKBA.O :
    * FDA PROVIDES AKEBIA THERAPEUTICS A PATH FORWARD FOR
VADADUSTAT
    * AKEBIA THERAPEUTICS - FDA DENIES FORMAL DISPUTE
RESOLUTION,
OUTLINES PATH TO RESUBMIT NDA FOR DIALYSIS-DEPENDENT PATIENTS
WITHOUT NEW CLINICAL STUDIES
    * AKEBIA THERAPEUTICS INC - AKEBIA PLANS TO REQUEST TYPE A
MEETING
AND THEN RESUBMIT NDA
    * AKEBIA THERAPEUTICS INC - PLANS TO REQUEST TYPE A MEETING
WITH
OND AS SOON AS POSSIBLE AND EXPECTS TO RESUBMIT NDA IN SECOND
HALF OF 2023

Source text for Eikon:  ID:nPn30vbwPa 
Further company coverage:  AKBA.O 

 ((Reuters.Briefs@thomsonreuters.com;))