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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. Homebuilder Confidence Holds Steady In September
Homebuilder confidence in the U.S. held steady in the month of September, according to a report released by the National Association of Home Builders on Tuesday. The report said the NAHB/Wells Fargo Housing Market Index came in at 32 in September, unchanged from August. Economists had expected the index to inch up to 33.
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U.S. Industrial Production Unexpectedly Inches Slightly Higher In August
Industrial production in the U.S. unexpectedly edged slightly higher in the month of August, according to a report released by the Federal Reserve on Tuesday. The Fed said industrial production crept up by 0.1 percent in August after falling by a downwardly revised 0.4 percent in July. Economists had expected industrial production to slip by 0.1 percent.
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U.S. Import Prices Unexpectedly Increase In August
A report released by the Labor Department on Tuesday showed import prices in the U.S. unexpectedly increased in the month of August. The Labor Department said import prices rose by 0.3 percent in August after inching up by a downwardly revised 0.2 percent in July. Economists had expected import prices to edge down by 0.1 percent.
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Canadian Market Drifts Lower In Cautious Trade
The Canadian market is down in negative territory Tuesday morning, as data showing an increase in the nation's consumer price inflation dimmed the extent of rate cuts this year although the Canadian central bank is widely expected to lower interest rate by 25 basis points on Wednesday.
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U.S. Retail Sales Climb 0.6% In August, Much More Than Expected
The Commerce Department released a report on Tuesday showing retail sales in the U.S. rose by much more than expected in the month of August. The report said retail sales climbed by 0.6 percent in August, matching an upwardly revised increase in July. Economists had expected retail sales to inch up by 0.2 percent compared to the 0.5 percent growth originally reported for the previous month.
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U.S. Industrial Production Unexpectedly Inches Up 0.1% In August
Industrial production in the U.S. unexpectedly edged slightly higher in the month of August, according to a report released by the Federal Reserve on Tuesday.
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Eurozone Industrial Production Recovers In July
Eurozone industrial production recovered at a moderate pace in July due to the rebound in consumer and capital goods output despite tariff threats, official data showed Tuesday. Industrial production registered a monthly growth of 0.3 percent, in contrast to the 0.6 percent decrease in June, Eurostat reported. However, the rate was slightly weaker than the forecast of 0.4 percent.
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