Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

RTTNews | 761日前
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 | 726日前
Bay Street Likely To Post New Highs

Bay Street Likely To Post New Highs

Canadian shares are likely to open on a firm note Tuesday morning with higher oil and bullion prices set to trigger buying in energy and materials sectors.
RTTNews | 11分前
Wall Street Likely To Open Flat

Wall Street Likely To Open Flat

Futures point to a somewhat flat start on Wall Street Tuesday morning. Data on manufacturing and services sector activity in the U.S. in the month of August, due after the opening bell, is likely to provide some direction to the market.
RTTNews | 51分前
Sweden Cuts Policy Rate By 25 Bps

Sweden Cuts Policy Rate By 25 Bps

Sweden's central bank cut its benchmark interest rate by 25 basis points in order to support economic recovery and signalled an end to the easing cycle. The executive board of the Riksbank decided to lower the policy rate by 25 basis points to 1.75 percent. The bank has reduced the rate by 200 basis points since it started policy easing in May 2024.
RTTNews | 57分前
FTSE 100 Flat; Kingfisher Soars On Higher Guidance

FTSE 100 Flat; Kingfisher Soars On Higher Guidance

U.K. stocks are turning in a mixed performance on Tuesday with investors digesting the flash data showing weak manufacturing and services sector activity in the month of September.
RTTNews | 1時50分前
Eurozone Private Sector Logs Strongest Growth In 16 Months

Eurozone Private Sector Logs Strongest Growth In 16 Months

The euro area private sector expanded the most in 16 months in September driven by the acceleration in services activity growth, flash survey results published by S&P Global revealed on Tuesday. At 51.2, the HCOB composite output index climbed slightly from August's 51.0 and was above forecast of 51.1. The index posted above the 50.0 no-change mark for the ninth straight month in September.
RTTNews | 2時0分前
CAC 40 Up 0.6%; STMicroElectronics Rises Sharply

CAC 40 Up 0.6%; STMicroElectronics Rises Sharply

Despite data showing a contraction in France's private sector activity in the month of September, French stocks are up firmly in positive territory Tuesday afternoon with data showing an acceleration in Eurozone private sector growth, and NVIDIA's plans to invest $100 billion in OpenAI aiding sentiment.
RTTNews | 2時17分前
Sensex, Nifty Recover From Early Lows

Sensex, Nifty Recover From Early Lows

Indian shares cut early losses to end on a flat note on Tuesday. While a weakening rupee, tariff worries and concerns regarding the latest H1-B visa fee change weighed on markets, Fed rate cut hopes, falling oil prices and reports of strong festive-season demand for automobiles helped limit overall losses in the broader market.
RTTNews | 2時35分前