FDA approves a Gilead Sciences supplemental NDA for Vemlidy (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B vi...
FDA clears a Synaptive Medical 510(k) for its near-infrared fluorescence visualization module, Modus IR, adding to the existing fluorescence offering ...
FDA approves a Medexus Pharmaceuticals supplemental BLA for Ixinity [coagulation factor IX (recombinant)] for treating pediatric patients under 12 yea...
Federal Register notice: FDA withdraws approval of 30 abbreviated new drug applications from multiple applicants because the drug products are no long...
Federal Register notice: FDA announces the over-the-counter Monograph Drug User Fee Program facility fee rates for fiscal year 2024.
FDA Office of Combination Products associate director for policy John Weiner moves to Office of Global Operations director, where he will oversee the ...
Boston Scientific recalls the PolarSheath Steerable Sheath 12F after the company identified a tooling error in manufacturing which may have caused del...
FDA clears a Neuronetics 510(k) for its NeuroStar Advanced Therapy for use as an adjunct for treating major depressive disorder in adolescent patients...
