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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. Factory Orders Pull Back Sharply In June
After reporting a substantial increase by new orders for U.S. manufactured goods in the previous month, the Commerce Department released a report on Monday showing factory orders pulled back sharply in the month of June. The Commerce Department said factory orders dove by 4.8 percent in June after soaring by an upwardly revised 8.3 percent in May.
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Weak Jobs Data Limits Dollar's Rebound
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Bay Street Seen Opening On Cautious Note
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FTSE 100 Modestly Higher; Lloyds Banking Group Rises Nearly 8%
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Indian Rupee Falls To 4-day Low Against U.S. Dollar
The Indian rupee weakened against the U.S. dollar in the European session on Monday, as investors await the announcement of the interest rate decision by the Reserve Bank of India (RBI) on Wednesday.
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CAC Moderately Higher As Stocks Recover From Recent Setback
The French stock market is up firmly in positive territory on Monday with several counters from across various sectors attracting buyers after last week's decline following a sweeping tariff announcement from U.S. President Donald Trump.
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