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Federal Register notice: FDA renews its Psychopharmacologic Drugs Advisory Committee for an additional two years beyond the charte...[ Price : $8.95]
FDA says its new LabelComp artificial intelligence tool automates the identification of adverse event changes in drug labeling upd...[ Price : $8.95]
FDA approves an sBLA expanding the endometrial cancer indication for GlaxoSmithKlines Jemperli.[ Price : $8.95]
Abbott issues a medical device correction for a small number of FreeStyle Libre 3 sensors because they may provide incorrect high ...[ Price : $8.95]
Novartis files a lawsuit against FDA that seeks to reverse the agencys recent approval of MSN Laboratories generic version of Nova...[ Price : $8.95]
FDA sends Telix Pharmaceuticals a refuse-to-file letter on its BLA for TLX250-CDx (89Zr-DFO-girentuximab), an investigational imag...[ Price : $8.95]
Three stakeholders recommend changes to an FDA draft guidance on human- and animal-derived materials in cell and gene therapeutic ...[ Price : $8.95]
FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage...