- FDA returns to releasing pharma rejection letters with 14 new CRLsThe FDA on Friday posted 14 new rejection letters to pharma companies online, days after HHS confirmed to Endpoints News that the agency had paused new CRL releases because of a pharma-backed ...Endpoints · 14d ago↗ source
- FDA rejects Hengrui-Elevar liver cancer drug combo for third timeFor the third time in about two years, the FDA has cited manufacturing deficiencies in rejecting a drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics intended to treat th…Endpoints · 14d ago↗ source
- CDER adds 100+ new employees in a quarter for first time since late 2024The FDA's drug center hired more new employees than it lost in a quarter for the first time since the Trump administration gutted the agency's ranks in April 2025. The FDA's