Bavarian Nordic — Marts 2021
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Mandagens aktier: Bavarian endte atter i front for positivt C25
https://www.proinvestor.com/investornyt/673356/mandagens-aktier-bavarian-endte-atter-i-front-for-positivt-c25 -
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“We are pleased by the FDA’s acceptance of the NDA for the dasiglucagon HypoPal
rescue pen, several weeks ahead of the anticipated response date. It marks an important step toward bringing a potential treatment option to people with diabetes at risk of severe hypoglycemia,” commented Adam Steensberg, Executive Vice President, Research and Development, and Chief Medical Officer at Zealand Pharma. “This represents yet another significant milestone achieved by the Zealand team. -
Zealand Pharma announces FDA acceptance of New Drug Application for the dasiglucagon HypoPal® rescue pen for treatment of severe hypoglycemia
Company Announcement – No. 28 / 2020 Zealand Pharma announces FDA acceptance of New Drug Application for the dasiglucagon HypoPal® rescue pen for...
GlobeNewswire News Room (www.globenewswire.com)
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Jeg har fundet indlægssedlen https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf
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Jeg har denne fra mit feed: (men er i tvivl)
Approval Date: 03/22/2021; Drug Name: Zegalogue, Nda #214231; Active Ingredients: DASIGLUCAGON; Company: Zealand Pharma As; Submission Status: Approval; Submission Classification: Type 1 - New Molecular Entity; Application Number: 214231
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