FDA approves Premia Spines TOPS System as an alternative to spinal fusion for treating certain patients with degenerative spondylolisthesis.
FDA publishes a CVM guidance entitled #171 Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Con...
FDA grants Genentech accelerated approval for its BLA for Columvi (glofitamab-gxbm) and its use in treating adult patients with relapsed or refractory...
FDA approves a Bristol Myers Squibb supplemental NDA to add positive data from its Phase 3 VALOR-HCM study to the U.S. prescribing information for hea...
FDA advises manufacturers that they should develop vaccines with a monovalent XBB.1.5 composition, according to a notice posted one day after an advis...
Reps. Schiff and Kuster introduce legislation to direct FDA to establish a process to allow generic drug manufacturers to update drug labeling with ne...
FDAs Vaccines and Related Biological Products Advisory Committee votes 21 to 0 that the Covid-19 vaccination program for the 2023-2024 season should c...
FDA researchers discuss ways to improve the use of AI/ML in precision medicine.
