Bavarian Nordic — Marts 2021
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Kunne godt forestille mig at afgørelsen fra FDA kan komme før tid. FDA's bekræftelse på at de har modtaget ansøgningen kom også en del tidligere end forventet tilbage i maj. Men vi krydser fingre og ser med spænding frem mod en forhåbentlig god uge for Zeal&
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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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