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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.
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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.
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656 dias atrás
Gold Dips As US-China Trade Talks Continue
Gold prices dipped on Tuesday, ahead of US inflation report and ongoing US-China official talks, which is now the focus of investors from all over the world.
Front Month Comex Gold for June delivery lost $11.20 (or 0.34%) to $3320.90 per troy ounce on Tuesday.
Front Month Comex Silver for June delivery lost $14.60 cents (or 0.40%) to $36.542 today.
The much-anticipated high-level trade talks between the world's two largest economies, U.S. and China, began on Monday in London and continued for the second day today.
On the economic data front, the US Labor Department will release Consumer Price Index (CPI) data on Wednesday, which may help to determine the Federal Reserve's monetary policy before the Fed's June 17-18 meeting.
Meanwhile, the World Bank, in its biannual Global Economic Prospects, has cut the global growth forecast to 2.3% from 2.7% for the current year citing "trade barriers" as a reason behind the global slowdown.
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17 minutos atrás
Crude Oil Prices Fade As US-China Talks Progress
Crude oil prices were down on Tuesday amidst uncertainty over trade talks between China and the United States continued, although the outcome remains uncertain.
WTI oil closed down by $0.31 to settle at $64.98 per barrel. August Brent crude was last seen down by $0.03 to $67.01.
To ease the standstill created by the reciprocal tariffs imposed by U.S. President Donald Trump and China, high-level officials from both nations convened at London on Monday to discuss steps to soften the conflict.
As the talks went on for the second day today, Trump told reporters at the White House that the talks were "going well" and that he was "only getting good reports." While U.S. Treasury Secretary Scott Bessent described Monday's talks as "good meeting," the Commerce Secretary Howard Lutnick called them as "fruitful."
On the geopolitical front, however, Russia showed no sign of relenting on its war with Ukraine and continued its attacks.
Limiting the downside, the U.S. Energy Information Administration has reported today that US crude oil production is likely to decline over the next 18 months - while the approach of the summer driving season is also good news.
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23 minutos atrás
Canadian Dollar Appreciates Amid Risk Appetite
The Canadian dollar climbed against its major counterparts in the New York session on Tuesday, as investors monitored trade talks between the U.S. and China that continued for a second day.
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1 h 3 min atrás
Swiss Market Ends Marginally Down
Save for a very brief while at the start, the Switzerland market stayed weak on Tuesday as investors refrained from making significant moves, choosing to wait for directional clues.
Investors awaited the outcome of the high-level trade discussions between U.S. and Chinese officials in London.
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2 h 28 min atrás
European Stocks Close On Mixed Note
European stocks turned in a mixed performance on Tuesday with investors mostly making cautious moves as they awaited the outcome of the ongoing Sino-U.S. trade talks in London.
German stocks are drifting lower on Tuesday as investors await the outcome of high-level U.S. - China trade talks in London.
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2 h 44 min atrás
TSX Up Marginally; Energy Stocks Rise
After a flat start and a subsequent climb up north, the Canadian market retreated Tuesday morning, and at a little past noon, was up marginally, led by gains in energy, consumer and communications sectors.
Investors are cautiously optimistic about some positive progress in U.S.-China trade relations.
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3 h 51 min atrás
U.S. Stocks Mostly Subdued In Lackluster Trade
U.S. stocks are turning in a mixed performance in lackluster trade on Tuesday as traders await the outcome of the ongoing trade talks between China and the U.S. in London.
Trade negotiations between the world's two largest economies commenced on Monday, and no big breakthrough seems to have been arrived as yet.
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4 h 28 min atrás
