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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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Před 380 dny
Swiss Market Ends On Positive Note
The Swiss market closed higher on Friday as easing concerns about trade tensions following the announcement of a trade deal between the U.S. and U.K., and upcoming talks between U.S. and China helped keep the mood positive.
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Před 12 minutami
European Stocks Close On Firm Note On Trade Deal Optimism, Earnings
European stocks closed higher on Friday amid optimism about the U.S. and China agreeing on a trade deal this weekend, close on the heels of U.S. President Donald Trump unveiling the framework of a trade agreement with the U.K. on Thursday.
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TSX Modestly Higher On Positive Jobs Data, Earnings Updates
The Canadian market is modestly higher around noon on Friday, riding on gains in communications, energy and materials sectors.
Optimism about the U.S. and China agreeing on a trade deal this weekend, close on the heels of U.S. President Donald Trump unveiling the framework of a trade agreemen
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Bay Street Headed For Positive Start
Firm commodity prices and steady global stocks amid optimism about trade deals point to a positive start for the Canadian market on Friday. Canadian jobs data for the month of April, and corporate earnings updates are also set to make an impact.
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Před 4 h 59 min
FTSE Up Nearly 0.5% On Easing Tariff Concerns
U.K. stocks are up on Friday, supported by some strong earnings updates, and continued optimism about trade deals.
U.S. President Donald Trump said on Thursday that the meetings with China on trade and economic issues could be "very substantive" and lead to tariff reductions.
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Před 6 h 41 min
CAC 40 Up 0.75% On Easing Trade Tensions
French stocks are exhibiting strength on Friday, buoyed by news about the U.S. and U.K. agreeing on a trade deal, and the upcoming U.S. - China trade talks this weekend.
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Před 7 h 16 min
Sensex, Nifty Extend Losses As Operation Sindoor Continues
Indian shares fell sharply on Friday to extend losses from the previous session after the Indian Army said it had countered the Pakistani attack on Indian cities late last night, fueling concerns of further escalation between the two nuclear-armed nations.
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Před 7 h 24 min
