A rare disease advocacy group tells Congress to increase FDA oversight, warning that inconsistent use of regulatory flexibility and a drop in advisory...
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.
FDA releases a list of 81 new and revised guidances in 12 categories that CDER plans to issue this calendar year.
FDA warns Ross Healthcare, in Lynden, WA, about CGMP violations in its production of finished drugs.
FDA accepts for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis.
