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 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.
In an unprecedented LinkedIn post, CDER director George Tidmarsh questions the use of surrogate endpoints and publicly attacks Aurinia Pharmas Lupus d...
The CDER Quantitative Medicine Center of Excellence issues a report on goals and accomplishments in the first 16 months of its existence.
