ロード中...

Advertisement

Akebia Therapeutics Resubmits NDA For Vadadustat To FDA

RTTNews | 678日前

Akebia Therapeutics Resubmits NDA For Vadadustat To FDA

(RTTNews) - 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.

Vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is currently approved for use in 35 countries.

Based on standard NDA resubmission review timelines, a letter from the FDA acknowledging that the resubmission is complete, classifying the resubmission, and setting the PDUFA date is expected in 30 days. Akebia expects the FDA to set a PDUFA date of six months from the date of submission.

For More Such Health News, visit rttnews.com

タグ: AKBA

read more

Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

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.

RTTNews | 713日前

Rebound Anticipated For Taiwan Stock Market

Rebound Anticipated For Taiwan Stock Market

The Taiwan stock market headed south again on Wednesday, one day after ending 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 beneath the 23,450-point plateau although it's likely to bounce higher again on Thursday.

RTTNews | 27分前

Higher Open Called For Singapore Stock Market

Higher Open Called For Singapore Stock Market

The Singapore stock market has climbed higher in three straight sessions, gathering more than 70 points or 1.7 percent along the way. The Straits Times Index now sits just above the 4,225-point plateau and it may see additional support again on Thursday.

RTTNews | 57分前

South Korea Has $14.27 Billion Current Account Surplus

South Korea Has $14.27 Billion Current Account Surplus

South Korea had a current account surplus of $14.27 billion in June, the Bank of Korea said on Thursday - up from $10.14 billion in May.

RTTNews | 1時19分前

Malaysia Shares Tipped To Open To The Upside

Malaysia Shares Tipped To Open To The Upside

The Malaysia stock market has moved higher in two straight sessions, collecting almost 15 points or 1 percent along the way. The Kuala Lumpur Composite Index now sits just above the 1,540-point plateau and it's got another green light for Thursday's trade.

RTTNews | 1時27分前

Japan Stock Market May Crack Resistance At 41,000 Points

Japan Stock Market May Crack Resistance At 41,000 Points

The Japan stock market has moved higher in back-to-back sessions, advancing more than 500 points or 1.2 percent along the way. The Nikkei 225 now sits just shy of the 40,800-point plateau and it's tipped to open in the green again on Thursday.

RTTNews | 1時42分前

Win Streak May Continue For South Korea Shares

Win Streak May Continue For South Korea Shares

The South Korea stock market has moved higher in three straight sessions, advancing almost 80 points or 2.7 percent along the way. The KOSPI now sits just shy of the 3,200-point plateau and it may add to its winnings again on Thursday.

RTTNews | 1時57分前

China Trade Data On Tap For Thursday

China Trade Data On Tap For Thursday

China will on Thursday release July figures for imports, exports and trade balance, highlighting a busy day for Asia-Pacific economic activity.

RTTNews | 2時57分前

利用規約 | プライバシー | サイトマップ | Site Map Calendar

© 2025 Myfxbook Ltd。全著作権所有。

ハイリスクの警告：外国為替取引にはハイリスクが伴っているので、全ての人に適しているとは限りません。レバレッジは、追加のリスクと損失のエクスポージャーを生み出します。外国為替取引を決定する前に、あなたの投資目的、経験レベル、リスク許容度を慎重に検討してください。初期投資の一部及びその全ての失う可能性があるので、必要最低限以上のお金は投資しないでください。外国為替取引に関連するリスクについては、自分自身で学んで質問がある場合は独立した財務や税務顧問に質問してください。データと情報は全て'そのままの形'で提供されます。それらは情報提供のみを目的としており、取引目的やアドバイスを目的としたものではありません。過去の実績は、将来の結果を示すものではありません。