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Novo Nordisk wins first FDA approval for long-acting

Sep. 1, 2020 The first weekly therapy for adult growth hormone deficiency (GHD) has arrived in the U.S. with FDA approval for Novo Nordisk A/S' Sogroya (somapacitan). It’s the first of Novo's regulatory filings for the medicine, also submitted in the EU and Japan, to win approval. Sogroya replaces endogenous growth hormone in adults who don't produce enough of it. Novo said it is working to finalize plans to make the therapy available and has not yet disclosed pricing. BioWorld Regulatory Endocrine/metabolic FDA

fda approval status hgh for anti-aging
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Study findings do not automatically establish clinical benefit, safety, dosing, or suitability for an individual.

Sep. 1, 2020

The first weekly therapy for adult growth hormone deficiency (GHD) has arrived in the U.S. with FDA approval for Novo Nordisk A/S' Sogroya (somapacitan). It’s the first of Novo's regulatory filings for the medicine, also submitted in the EU and Japan, to win approval. Sogroya replaces endogenous growth hormone in adults who don't produce enough of it. Novo said it is working to finalize plans to make the therapy available and has not yet disclosed pricing.

BioWorld Regulatory Endocrine/metabolic FDA

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