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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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U.S. Dollar Falls As Weak Jobs Data Lifts Rate Cut Hopes
The U.S. dollar weakened against its major counterparts in the New York session on Friday, as weaker-than-expected jobs data for July strengthened expectations of a Fed rate cut in September.
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European Stocks Close Sharply Lower As Trump's Tariff Move Hurts Sentiment
European stocks tumbled on Friday, recording one of their worst sessions in several months, as sweeping fresh tariffs announced by U.S. President Donald Trump raised fears of a global economic slowdown, prompting investors to press selling across the board.
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Canadian Market Remains Firmly Down In Negative Territory On Tariff Worries
The Canadian market got off to a weak start Friday morning and slipped deeper into the red subsequently, as U.S. President Donald Trump's sweeping tariff announcement rendered the mood bearish.
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U.S. Construction Spending Unexpectedly Sees Further Downside In June
The Commerce Department released a report on Friday unexpectedly showing a continued decrease by U.S. construction spending in the month of June. The report said construction spending fell by 0.4 percent to an annual rate of $2.136 trillion in June after sliding by 0.5 percent to a revised rate of $2.144 trillion in May.
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U.S. Consumer Sentiment Improves Marginally Less Than Previously Estimated In July
Revised data released by the University of Michigan on Friday showed consumer sentiment in the U.S. improved marginally less than previously estimated in the month of July. The University of Michigan said its consumer sentiment index for July was downwardly revised to 61.7 from a preliminary reading of 61.8. Economists had expected the index to be upwardly revised to 62.0.
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U.S. Manufacturing Index Unexpectedly Dips To Nine-Month Low In July
Manufacturing activity in the U.S. unexpectedly contracted at a slightly faster rate in the month of July, according to a report released by the Institute for Supply Management on Friday. The ISM said its manufacturing PMI edged down to 48.0 in July after inching up to 49.0 in June with a reading below 50 indicating contraction.
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Eurozone Inflation Steady At 2% ECB Target
Euro area consumer price inflation was unchanged at the European Central Bank's 2 percent target in July, easing the pressure for more easing. The harmonized index of consumer prices increased 2.0 percent year-on-year in July, the same rate of increase as seen in June. Inflation was forecast to ease marginally to 1.9 percent.
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