A rare disease advocacy group tells Congress to increase FDA oversight, warning that inconsistent use of regulatory flexibility and a drop in advisory...
The U.S. Senate Special Committee on Aging raises concerns about FDAs handling of foreign drug manufacturing violations and how those decisions could ...
FDA accepts for priority review an Ionis Pharmaceuticals supplemental NDA for olezarsen for treating severe hypertriglyceridemia.
Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.
FDA approves a Sanofi and Regeneron Pharmaceuticals BLA supplement for Dupixent (dupilumab) and its use for treating adults and children ages 6 and ol...
FDA issues an early alert about a potentially high-risk problem involving certain heart pump components manufactured by Abiomed, warning that a malfun...
CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advances, collaborative sci...
Rep. Josh Gottheimer introduces several bills to mark Rare Disease Week.
