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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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463天前
Japanese Market Notably Lower
Reversing the gains in the previous session, the Japanese market is notably lower on Friday, following the broadly negative cues from Wall Street overnight. The Nikkei 225 is falling below the 40,700 level, with weakness in financial and technology stocks partially offset by gains in exporters and automaker stocks.
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Australian Market Notably Lower
The Australian stock market is trading notably lower on Friday, extending the losses in the previous session, following the broadly negative cues from Wall Street overnight. The benchmark S&P/ASX 200 is falling below the 8,700 level, with weakness across most sectors led by energy and technology stocks.
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