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 ...
Three stakeholders recommend changes to an FDA draft guidance on human- and animal-derived materials in cell and gene therapeutic materials.
FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage forms.
FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.
