Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

RTTNews | 712天前
Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

(RTTNews) - Biopharmaceutical company Akebia Therapeutics, Inc. (AKBA) announced Thursday that the company expects to resubmit its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease in adult patients on dialysis by the end of the third quarter of 2023.

Upon acceptance of the NDA, Akebia expects the U.S. Food and Drug Administration (FDA) to set a PDUFA date of six months from the date of submission.

Akebia received Meeting Minutes summarizing the productive and informative discussion held during an End of Dispute Type A meeting with the FDA in July 2023. The minutes reflect Akebia's plan for the NDA resubmission discussed at the meeting.

Vadadustat is currently approved for use in 34 countries.

For More Such Health News, visit rttnews.com

read more
Akebia Therapeutics Resubmits NDA For Vadadustat To FDA

Akebia Therapeutics Resubmits NDA For Vadadustat To FDA

Biopharmaceutical company Akebia Therapeutics, Inc. (AKBA) announced Thursday it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
RTTNews | 677天前
U.S. Service Sector Growth Unexpectedly Slows In July

U.S. Service Sector Growth Unexpectedly Slows In July

A report released by the Institute for Supply Management on Tuesday unexpectedly showed a modest slowdown in the pace of growth by U.S. service sector activity in the month of July. The ISM said its services PMI edged down to 50.1 in July from 50.8 in June. While a reading above 50 still indicates growth, economists had expected the index to rise to 51.5.
RTTNews | 36分鐘前
U.S. Trade Deficit Narrows To $60.2 Billion In June As Imports Plunge

U.S. Trade Deficit Narrows To $60.2 Billion In June As Imports Plunge

The U.S. trade deficit narrowed by slightly more than anticipated in the month of June, according to a report released by the Commerce Department on Tuesday. The Commerce Department said the trade deficit shrank to $60.2 billion in June from a revised $71.7 billion in May.
RTTNews | 1小時22分鐘前
Eurozone Private Sector Continues To Expand

Eurozone Private Sector Continues To Expand

Euro area private sector remained in the expansionary territory in July but the rate of growth remained sluggish as stagnant demand pulled back production, final survey results of the purchasing managers' survey by S&P Global showed on Tuesday. The HCOB composite output index rose to 50.9 in July from 50.6 in June. The flash reading was 51.0. A score above 50.0 indicates expansion.
RTTNews | 2小時30分鐘前
Bay Street May Open Slightly Higher

Bay Street May Open Slightly Higher

Canadian stocks may open on a positive note Tuesday morning amid expectations of a rate cut by the Federal Reserve next month. The focus will be on trade talks between Canad and Mexico.
RTTNews | 2小時41分鐘前
FTSE 100 Advances On Upbeat Earnings

FTSE 100 Advances On Upbeat Earnings

The UK market is modestly higher on Tuesday, extending gains from previous session, thanks to some upbeat corporate earnings announcements, and expectations that the Federal Reserve will cut interest rate in the near future to spur economic growth.
RTTNews | 3小時10分鐘前
Pound Rises As Traders Await BoE Monetary Policy Meeting

Pound Rises As Traders Await BoE Monetary Policy Meeting

The British pound strengthened against other major currencies in the European session on Tuesday, as traders shift their focus to the Bank of England's (BoE) monetary policy announcement on Thursday.
RTTNews | 3小時21分鐘前