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Ascendis Pharma Says FDA Accepts Resubmitted NDA For TransCon PTH In Adults With Hypoparathyroidism
(RTTNews) - Ascendis Pharma A/S (ASND) announced Monday that the U.S. Food & Drug Administration (FDA) has accepted for review the Company's resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism.
The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act (PDUFA) goal date of May 14, 2024.
In the United States, TransCon PTH (palopegteriparatide) is an investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism.
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Ascendis Pharma Says UK Approves YORVIPATH For Treatment Of Adults With Chronic Hypoparathyroidism
Danish pharmaceutical company Ascendis Pharma A/S (ASND) announced that the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for YORVIPATH (palopegteriparatide; developed as TransCon PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism
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466 วันที่ผ่านมา
European Economic News Preview: Eurozone Sentix Investor Confidence Due
Investor confidence from the euro area and unemployment from Spain are the top economic news due on Monday. At 2.30 am ET, the Federal Statistical Office publishes Swiss inflation data for July. Economists forecast consumer prices to rise 0.1 percent year-on-year, the same rate of increase as seen in June.
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4 นาทีที่ผ่านมา
European Shares Seen Tad Higher At Open
European stocks may open on a positive note Monday as investors keep an eye on the latest batch of earnings and watch further developments on the tariff front.
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21 นาทีที่ผ่านมา
Sensex, Nifty Give Up Early Gains; IT And Pharma Stocks Drag
Indian shares were little changed on Monday, giving up some early gains, with rising trade tensions with the U.S., mixed earnings results and continued foreign fund outflows keeping investors on edge.
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1 ชม. 40 นาทีที่ผ่านมา
Australian Market Extends Early Losses In Mid-market
The Australian stock market is extending its early losses in choppy mid-market trading on Monday, also adding to the losses in the previous two sessions, following the broadly negative cues from Wall Street on Friday. The benchmark S&P/ASX 200 index is falling below the 8,650.00 level, with weakness in energy, financial and technology stocks partially offset by strong gains in mining stocks.
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2 ชม. 19 นาทีที่ผ่านมา
Asian Markets Trade Mixed
Asian stock markets are trading mixed on Monday, following the negative cues from Wall Street on Friday, amid concerns about the economic impact of US President Donald Trump's unilateral "reciprocal tariffs" and aggressive trade stance on the global economy. However, the weaker than expected US monthly jobs data increased optimism about a potential interest rate cut by the US Fed in September.
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3 ชม. 0 นาทีที่ผ่านมา
Sensex, Nifty Seen Tad Higher At Open
Indian shares look set to open on a positive note Monday after two consecutive sessions of losses.
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3 ชม. 29 นาทีที่ผ่านมา
Thai Stock Market Expected To Open In The Red Again On Monday
The Thai stock market has moved lower in consecutive trading days, falling more than 25 points or 2 percent along the way. The Stock Exchange of Thailand now sits just beneath the 1,220-point plateau and it's likely in for a rough ride again on Monday.
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4 ชม. 2 นาทีที่ผ่านมา
