FDA awards Boehringer Ingelheim Pharmaceuticals an accelerated approval for Hernexeos (zongertinib) for certain adults with unresectable or metastatic...
FDA prepares to roll out a new bonus program that will reward drug and biologic reviewers for completing high-quality reviews ahead of schedule.
An FDA Voices post by FDA chief operating officer Barclay Butler says the agencys ability to uphold the gold standard of regulatory review depends as ...
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.
