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.
Attorneys from DLA Piper complain that a new final FDA guidance on Clinical Decision Support (CDS) Software appears to be more expansive in scope than...
Eugia U.S. (formerly AuroMedics Pharma) recalls one lot of acyclovir sodium injection 500 mg per 10 mL single dose vials due to a product complaint ab...
The Senate unanimously approves legislation to end an FDA mandate for animal testing of experimental drugs before they can be used in human clinical t...
FDA clears a Medtronic 510(k) for its Nexpowder endoscopic hemostasis system.
