FDA adds important information to the emergency authorization of AstraZenecas Evusheld to inform health care providers and individuals about the incre...
FDA posts a draft guidance entitled Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA that introduces an enhancement unde...
FDA awards the Biologics & Biosimilars Collective Intelligence Consortium a $1.3 million grant to support biosimilars research and a study focused on ...
FDA clears a GE Healthcare 510(k) clearance for its AIR Recon DL for 3D and Propeller imaging sequences for use during magnetic resonance imaging clin...
BioMarin refiles its BLA for gene therapy valoctocogene roxaparvovec for adults with severe hemophilia A.
LivaNova (TandemLife) recalls its LifeSPARC Controller, part of the LifeSPARC blood pump system, due to a software malfunction.
A bill, which was attached to a continuing resolution, reauthorizing FDAs user fee programs is signed into law by President Biden.
An HHS Inspector General data snapshot finds that more than one-third of accelerated drug approvals have delinquent confirmatory trial completions.
