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Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

RTTNews | 712 일 전

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.

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태그 : AKBA

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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 일 전

New Zealand Jobless Rate Climbs To 5.2% In Q2

New Zealand Jobless Rate Climbs To 5.2% In Q2

The unemployment rate in New Zealand came in at a seasonally adjusted 5.2 percent in the second quarter of 2025, Statistics New Zealand said on Wednesday.

RTTNews | 28 분 전

Taiwan Shares May Head South Again On Wednesday

Taiwan Shares May Head South Again On Wednesday

The Taiwan stock market on Tuesday wrote a finish to the two-day losing streak in which it had slipped more than 270 points or 1.2 percent. The Taiwan Stock Exchange now sits just above the 23,660-point plateau although it may see renewed consolidation on Wednesday.

RTTNews | 31 분 전

Singapore Stock Market May Spin Its Wheels On Wednesday

Singapore Stock Market May Spin Its Wheels On Wednesday

The Singapore stock market has climbed higher in two straight sessions, gathering more than 50 points or 1.2 percent along the way. The Straits Times Index now sits just beneath the 4,210-point plateau although it may be stuck in neutral on Wednesday.

RTTNews | 1 시간 1 분 전

Malaysia Bourse May Hand Back Tuesday's Gains

Malaysia Bourse May Hand Back Tuesday's Gains

The Malaysia stock market has alternated between positive and negative finishes through the last five trading days since the end of the three-day losing streak in which it had fallen more than 15 points or 1 percent. The Kuala Lumpur Composite Index now sits just beneath the 1,540-point plateau and it's likely to remain rangebound again on Wednesday.

RTTNews | 1 시간 31 분 전

Japan Shares May Turn Lower Again On Wednesday

Japan Shares May Turn Lower Again On Wednesday

The Japan stock market on Tuesday wrote a finish to the two-day slide in which it had tumbled almost 780 points or 1.8 percent. The Nikkei 225 now sits just shy of the 40,550-point plateau although it may head south again on Wednesday.

RTTNews | 1 시간 46 분 전

South Korea Shares May Be Stuck In Neutral

South Korea Shares May Be Stuck In Neutral

The South Korea stock market has moved higher in back-to-back sessions, advancing almost 80 points or 2.7 percent along the way. The KOSPI now sits just shy of the 3,200-point plateau although the rally may stall on Wednesday.

RTTNews | 2 시간 1 분 전

New Zealand Unemployment Data Due On Wednesday

New Zealand Unemployment Data Due On Wednesday

New Zealand will on Wednesday release Q2 figures for unemployment, highlighting a modest day for Asia-Pacific economic activity. The jobless rate is expected to tick up to 5.3 percent from 5.1 percent following a 0.1 percent loss in employment.

RTTNews | 3 시간 1 분 전

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