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Home » Uncertainty sinks Ascendis, rocked by FDA ‘deficiencies’ ahead of upcoming Transcon PTH PDUFA date
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Uncertainty sinks Ascendis, rocked by FDA ‘deficiencies’ ahead of upcoming Transcon PTH PDUFA date

April 3, 2023
By Jennifer Boggs
A frustrating lack of detail left analysts with little to do but speculate on the odds for a 2023 U.S. FDA approval of Ascendis Pharma A/S’s Transcon PTH (palopegteriparatide), a parathyroid hormone prodrug for hypoparathyroidism, after the company disclosed a letter from the agency citing unspecified deficiencies that preclude further discussions about labeling and postmarketing requirements.
BioWorld Regulatory U.S.

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