AbbVie files a BLA seeking approval for its investigational antibody-drug conjugate pivekimab sunirine to treat blastic plasmacytoid dendritic cell ne...
The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising, citing First Amendment protection for commercial ...
FDA releases a list of eight Generic Drug User Fee Act science and research priorities for FY 2026, covering 23 separate initiatives.
FDA clears a UroViu 510(k) for its UV5000 cordless, single-use endoscope platform.
FDA approves a Zoll Medical PMA for Zenix, the companys newest monitor/defibrillator, which the company says is designed to streamline emergency and h...
FDA researchers say the OND Custom Medical Queries developed to improve the identification and analysis of new drug safety signals have improved FDAs ...
FDA warns San Francisco, CA-based dentist Pamela Den Besten about conducting a clinical trial on an investigational drug without an IND in place.
FDA warns Glendale, CA-based Persōn & Covey about CGMP violations in its production of unapproved drugs.
