Advertisement
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
read more
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
|
711 dni temu
Indonesia GDP Growth Fastest In 2 Years
Indonesia's economic growth accelerated the most in two years in the second quarter driven by household spending and investment, official data showed Tuesday. Gross domestic product expanded 5.12 percent year-on-year in the second quarter, following an annual growth of 4.87 percent seen in the first quarter. The latest expansion was the fastest since the second quarter of 2023.
RTTNews
|
53 minut temu
China Services Growth Fastest Since May 2024
China's services activity expanded at the fastest pace in more than a year in July on rising inflows of new business, purchasing managers' survey data from S&P Global showed on Tuesday. The headline general services business activity index rose to 52.6 in July from 50.6 in June. The index extended the current period of growth to just over two-and-a-half years. Moreover, the index suggested that t
RTTNews
|
2g 4 minut temu
European Economic News Preview: Eurozone Final Composite PMI Data Due
Composite Purchasing Managers' survey results from the euro area and other major euro area economies are due on Tuesday. At 2.45 am ET, France's statistical office INSEE publishes industrial output data for June. Production is forecast to grow 0.8 percent on a monthly basis, in contrast to the 0.5 percent fall in May. At 3.00 am ET, Spain's INE publishes industrial output data for June.
RTTNews
|
2g 28 minut temu
European Shares Set To Open On Firm Note
European stocks are seen opening higher on Tuesday as investors await the next batch of earnings and any new developments on the trade front.
RTTNews
|
2g 33 minut temu
Sensex, Nifty Open Lower After Trump's Fresh Tariff Threat
Indian shares opened on a sluggish note Tuesday after U.S. President Donald Trump threatened to "substantially" raise tariffs on goods imported from India, accusing that the country profited from Russia's war in Ukraine by purchasing large quantities of Russian oil and reselling it on the global market.
RTTNews
|
3g 34 minut temu
Australian Market Extends Early Gains In Mid-market
The Australian stock market is extending its early gains in mid-market trading on Tuesday, adding to the gains in the previous session, following the broadly positive cues from Wall Street overnight. The benchmark S&P/ASX 200 is moving above the 8,750 level, with gains across all sectors led by mining, energy and technology stocks.
RTTNews
|
4g 39 minut temu
Asian Markets Track Wall Street Higher
Asian stock markets are trading mostly higher on Tuesday, following the broadly positive cues from Wall Street overnight, amid optimism the weak monthly US jobs data will lead the US Fed to lower interest rates next month. Traders also picked up stocks at a bargain following the recent downturn in the markets. Asian markets closed mixed on Monday.
RTTNews
|
5g 5 minut temu
