FDA extends action date 90 days for Xeris Pharma’s glucagon rescue pen

The FDA has extended its action date to September 10 for its review of Xeris Pharmaceuticals’ (NASDAQ:XERS) marking application for Gvoke (ready-to-use glucagon injection) for the treatment of severe hypoglycemia (low blood sugar).

The 90-day extension is standard operating procedure for the agency when there is a major amendment to an NDA. In this case, additional information requested by the review team constituted such an amendment.

https://seekingalpha.com/news/3469679-fda-extends-action-date-90-days-xeris-pharmas-glucagon-rescue-pen