Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.
FDA sends an untitled letter to Pinnacle Biologics, citing promotional videos for cancer therapy Photofrin (porfimer sodium).
FDA approves Gilead Sciences Trodelvy (sacituzumab govitecan-hziy) for first-line treatment of adults with unresectable locally advanced or metastatic...
FDA says it will not accept medical device test data generated by CCIC Huatongwei International Inspection in China because the agency has found sever...
Speaking at the BIO 2026 convention, former FDAers criticize the informal way in which agency policy was made and announced under former commissioner ...
Sen. Tom Cotton (R-AR) introduces a bill that would require FDA to review and potentially recall Chinese-manufactured networked medical devices deemed...
CeleCor Therapeutics says it has submitted an NDA for Disaggpro (zalunfiban), an investigational treatment for ST-segment elevation myocardial infarct...
The FY2025 FDA Report on the State of Pharmaceutical Quality shows increased quality assurance inspections over FY 2024.
