Bavarian Nordic — Marts 2021
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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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ZEAL: Zealand Sp ADR Latest Stock Price, Analysis, News and Trading Ideas
Get real-time Zealand Sp ADR (ZEAL) stock price, news, financials, community insights, and trading ideas. Join 10 million+ investors and traders tracking markets in real-time on Stocktwits.
Stocktwits (stocktwits.com)
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Zealand Pharma (NASDAQ:ZEAL) rose in late trading hours to end the day with a ~12.9% gain on the news that its glucagon analog dasiglucagon, with the brand name Zegalogue, won FDA approval, according to a posting on the federal agency’s website.The company hasn’t officially released a statement yet.
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The PDUFA was March 27 for the company’s marketing application for dasiglucagon for congenital hyperinsulinism.Zealand Pharma dropped sharply in December on the announcement of topline data from the first Phase 3 trial evaluating dasiglucagon as a treatment of Congenital Hyperinsulinism (“CHI”).
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Zealand Pharma surges on news of FDA approval for dasiglucagon
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ZEGALOGUE (dasiglucagon) injection, for subcutaneous use. Initial U.S. Approval: 2021:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf
rescue pen - så er der da basis for lidt mere i løbet af ugen 
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