Intellia Therapeutics ( NTLA) on Tuesday announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) and granted Priority Review for lonvoguran ...
The FDA accepted Intellia’s Biologics License Application for lonvoguran Ziclumeran for Hereditary Angioedema.
Phase 3 HAELO data showed an 87% reduction in monthly attack rates with Ionvoguran ziclumeran, with a PDUFA target date of March 10, 2027.
A Prescription Drug User Fee Act target date of February 28, 2026 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ...
A recent clinical review and editorial synthesized in The Journal of Obstetrics and Gynecology of India in August 2026 ...