FDA says its new LabelComp artificial intelligence tool automates the identification of adverse event changes in drug labeling updates.
FDA approves an sBLA expanding the endometrial cancer indication for GlaxoSmithKlines Jemperli.
Abbott issues a medical device correction for a small number of FreeStyle Libre 3 sensors because they may provide incorrect high glucose readings.
Novartis files a lawsuit against FDA that seeks to reverse the agencys recent approval of MSN Laboratories generic version of Novartiss Entresto (sacu...
FDA sends Telix Pharmaceuticals a refuse-to-file letter on its BLA for TLX250-CDx (89Zr-DFO-girentuximab), an investigational imaging agent for clear ...
The Justice Department says a resident of India has been indicted on federal charges of trafficking in fake cancer drugs sold in the U.S.
The CDER Quantitative Medicine Center of Excellence posts four new resources.
Federal Register notice: FDA set biosimilar user fee rates for fiscal year 2025.
