Hypoparathyroidism
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EMA approval · 2025-07-15EMA Authorised: Natpar (parathyroid hormone) — Takeda Pharmaceuticals International AG Ireland Branch
EU authorises Natpar (parathyroid hormone) for hypoparathyroidism. The decision includes conditional approval and orphan medicine designatio…
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CLINICAL_TRIALS approval · 2025-06-27Clinical Trial Update: Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism
The expanded access program for Palopegteriparatide in hypoparathyroidism has been approved for marketing.
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EMA approval · 2025-06-20EMA Authorised: Yorvipath (palopegteriparatide) — Ascendis Pharma Bone Diseases A/S
The EMA has authorised Yorvipath (palopegteriparatide) from Ascendis Pharma Bone Diseases A/S for the treatment of hypoparathyroidism and ha…
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FDA approval · 2019-02-21FDA Approved: CALCITRIOL — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a generic calcitriol product from Sun Pharmaceutical Industries under an original ANDA, enabling another generic calcitriol opt…
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FDA approval · 2018-11-21FDA Approved: CALCITRIOL — Original Application (Rising Pharma Holdings, Inc.)
FDA approved an original Abbreviated New Drug Application for calcitriol by Rising Pharma Holdings, Inc., providing a generic version of the…
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FDA approval · 2017-06-15FDA Approved: CALCIUM GLUCONATE — Original Application (Fresenius Kabi USA, LLC)
The FDA approved Fresenius Kabi USA, LLC's calcium gluconate product under an original NDA.
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FDA approval · 2017-06-14FDA Approved: CALCITRIOL — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' generic calcitriol (1,25-dihydroxyvitamin D3). The approval is an Original Application for this generic…
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FDA approval · 2013-05-24FDA Approved: CALCITRIOL — Original Application (BIONPHARMA INC.)
FDA approved the original ANDA application for Calcitriol from BIONPHARMA INC., a generic version of the active vitamin D3 analog.