Breaking News, Trials & Filings

Zealand Pharma Faces FDA Delays for Dasiglucagon

Provides U.S. regulatory update.

Author Image

By: Charlie Sternberg

Associate Editor

Zealand Pharma A/S, a biotechnology company focused on peptide-based therapeutics, announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for Part 1 of its New Drug Application (NDA) for dasiglucagon. Dasiglucagon is being developed for the prevention and treatment of hypoglycemia in pediatric patients with congenital hyperinsulinism (CHI).     The FDA’s decision to issue a CRL was primarily due to an ongoing inspection of a...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters