Bavarian Nordic — Marts 2021
-
“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. -
Jeg har fundet indlægssedlen https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf
-
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
-
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)
-
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.
-
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”).
-
Zealand Pharma surges on news of FDA approval for dasiglucagon
-
ZEGALOGUE (dasiglucagon) injection, for subcutaneous use. Initial U.S. Approval: 2021:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf
Hello! It looks like you're interested in this conversation, but you don't have an account yet.
Getting fed up of having to scroll through the same posts each visit? When you register for an account, you'll always come back to exactly where you were before, and choose to be notified of new replies (either via email, or push notification). You'll also be able to save bookmarks and upvote posts to show your appreciation to other community members.
With your input, this post could be even better 💗
Tilmeld Log ind