FDA warns Chinas Linghai ZhanWang Biotechnology Co. about CGMP violations in its manufacturing of over-the-counter drugs.
Pfizer and Arvinas announce positive topline results from a clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in certain adults w...
FDA tells Chinas Mid-Link Technology Testing Co. it is rejecting all data from all studies conducted by the company until it provides a substantive re...
Two clinical research facility owners plead guilty in Florida federal court to conspiracy to commit wire fraud in connection with their work on two cl...
FDA warns six companies that they are marketing unapproved fat-dissolving drugs.
FDA accepts a Sydnexis NDA for SYD-101 (topical low-dose atropine) for treating progression of pediatric myopia.dr
CDRH chief scientist and deputy Center director Doug Kelly abruptly resigns after less than five years at the agency.
FDA clears a Beckman Coulter Diagnostics 510(k) for its DxC 500i Clinical Analyzer.
