FDA Matters president Steven Grossman says FDAs top officials can improve agency morale by increasing the trust felt by lower-level staff that they ar...
FDA warns Chinas Taizhou Kangping Medical Science and Technology Co. about CGMP violations in its manufacturing of over-the-counter drugs.
FDA names 26-year FDA veteran Richard Pazdur as the new CDER director, replacing George Tidmarsh after he recently stepped down amid an internal ethic...
FDA grants Avenzo Therapeutics a fast track designation for AVZO-1418, the companys investigational EGFR/HER3 bispecific antibody-drug conjugate being...
FDA says it will begin removing broad boxed warnings from menopause-related hormone replacement therapy products based on a recent safety review.
Roche says its investigational Brutons tyrosine kinase inhibitor fenebrutinib showed the strongest late-stage results yet reported for the drug class ...
FDA cites Alvotechs Reykjavik, Iceland, manufacturing site for widespread sterility assurance, environmental monitoring, and quality-system failures f...
Merck reports positive Phase 3 results for its oral PCSK9 inhibitor enlicitide, showing LDL-cholesterol reductions approaching 60% with a safety profi...
