Fast Track status enables closer FDA engagement to potentially accelerate development of a CDH6-directed ADC in ...

LTG-001 demonstrated rapid absorption with a Tmax of approximately 1.5 hours. The Food and Drug Administration (FDA) has granted Fast Track designation to LTG-001 for the treatment of acute pain.

Treatment with nipocalimab led to reduced lupus disease activity in phase 2 trial. (HealthDay News) — Nipocalimab has been granted U.S. Food and Drug Administration Fast Track designation as a ...

The FDA's Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions. The Food and Drug Administration (FDA) has granted Fast Track ...