Elevar Therapeutics, Inc.

Despite the ongoing upheaval across the agency, the US Food and Drug Administration maintained its typical reliability when it came to meeting user fee goal dates in the first quarter of 2025, the Pi

“Pipeline in a pill”-style drug development will be on display in April, when more than half of the user fee goal dates are for new indications on sometimes sprawling labels, as well as one novel biol

Elevar Therapeutics, a US subsidiary of South Korea’s HLB LifeScience, and China’s Jiangsu Hengrui Pharmaceuticals on 21 March received a complete response letter from the US Food and Drug Administrat

The disruption of existing markets is a dominant ambition of the nearly 20 applications expecting US Food and Drug Administration action in March. The Pink Sheet ’s US FDA Performance Tracker shows