The FDA Medical Device Development Tool program qualifies the University of California San Francisco Lethal Arrhythmia Database.
FDA approves Basilea Pharmaceuticas antibiotic Zevtera for three indications.
Lenz Therapeutics says it will file an NDA for aceclidine eye drops in a few months after reporting Phase 3 study results for treating presbyopia, whi...
FDA grants Prenosis a de novo marketing authorization for its Sepsis ImmunoScore, an artificial intelligence/machine learning software for guiding rap...
The CDER Office of Pharmaceutical Quality outlines its accomplishments in 2023 under four strategic priorities.
Several stakeholder organizations say they appreciate that FDA revised its draft guidance on regulatory review assessments and suggest some additional...
FDA warns Mexicos Betone SA de CV about CGMP violations in its manufacturing of finished drugs.
FDA warns San Diego, CA-based Agena Bioscience about multiple violations in its manufacturing of a colon diagnostic panel as part of its MassARRAY4 sy...
